CN104288643A

CN104288643A - Pharmaceutical composition for treating consumptive disease nocturnal emission and preparation method thereof

Info

Publication number: CN104288643A
Application number: CN201410561930.4A
Authority: CN
Inventors: 赵岚
Original assignee: Zhejiang Industry and Trade Vocational College
Current assignee: Zhejiang Industry and Trade Vocational College
Priority date: 2014-10-21
Filing date: 2014-10-21
Publication date: 2015-01-21

Abstract

The invention discloses a pharmaceutical composition for treating consumptive disease nocturnal emission and a preparation method thereof. The pharmaceutical composition comprises the following ingredients in parts by weight: 10-30 parts of rehmannia glutinosa, 5-10 parts jujube kernel, 5-10 parts of coix seed, 4-8 parts of dogwood, 2-6 parts of poria with hostwood, 5-10 parts of poria cocos, 5-10 parts of angelica sinensis, 5-10 parts of radix paeoniae alba, 1-3 parts of five flavours, 1-3 parts of semen brassicae, 0.3-0.6 part of cinnamon, 0.3-0.5 part of coptis chinensis, 10-30 parts of red halloysite, 5-10 parts of dark plum, 5-10 parts of lotus seed, 4-8 parts of ginkgo, 2-6 parts of rhizome curculiginis, 5-10 parts of fructus alpiniae oxyphyllae, 5-10 parts of fructus paoraleae, 5-10 parts of drynaria rhizome, 1-3 parts of walnut meat, 1-3 parts of liquorice, 0.3-0.6 part of raspberry, 0.3-0.5 part of light wheat and 5-10 parts of fleece-flower root. The invention also discloses a preparation method of the pharmaceutical composition. The external-use pharmaceutical composition is scientific and reasonable in component compatibility, is a pure traditional Chinese medicine preparation, can rapidly eliminate the phenomenon of nocturnal emission, invigorate health and is unlikely to replase after healing.

Description

A kind of pharmaceutical composition and preparation method thereof for the treatment of asthenia seminal emission

Technical field

The present invention relates to the field of Chinese medicines, particularly relate to a kind of pharmaceutical composition and preparation method thereof for the treatment of asthenia seminal emission.

Background technology

Seminal emission refers to the disease that seminal fluid does not release voluntarily because of sexual intercourse, has physiological different from pathologic.Seminal fluid is claimed seminal emission or consumption of essence from losing phenomenon by the traditional Chinese medical science.Have dream and something lost person is called " nocturnal emission ", lose without dream, time even clear-headed, seminal fluid does not skid off person is voluntarily " spermatorrhea ".How closed solid by essence of suffering from a deficiency of the kidney, or disarmony between the heart and kidney, or caused by damp invasion of lower energizer, common simultaneous phenomenon have: giddy, tinnitus, forgetful, cardiopalmus, insomnia, the soreness of waist, lethargy etc." Jing Yue's complete work is deficient ": " sick is deficient, abnormal different, and because there being five kinds of strain and seven kinds of impairment, card has battalion to defend internal organs.So then people is rely survivor, only this vital essence in a word, and disease only deficient person, also only this vital essence.Deficiency of vital energy person, namely yang deficiency is also; The empty person of essence, namely the deficiency of YIN also." passing out semen frequently belongs to the performance of deficiency of the kidney yin, the clinical manifestation of deficiency of the kidney yin may be summarized to be ten aspects: soreness of waist and knee joint is due to deficiency of kidney yin, and marrow subtracts weak bone, and skeleton loses supports; Dizziness and tinnitus then fills because brain is lost; Insomnia and dreamful sleep reason is discordance between water and fire, and heart-fire is partially high, malaise; It is because monarch fire is not peaceful that essence lets out nocturnal emission, disturbing the essence-chamber; Emaciated physique, dry pharynx flushed cheeks comes from deficiency of kidney-YIN; Hectic fever night sweat, dysphoria with feverish sensation in the chest palms and soles, yellow urine dry stool is all in deficiency-heat raw; Red tongue with a little fluid, thready and rapid pulse is the card of the deficiency of YIN.

Have the discussion of " lack of vital essence resulting in deficiency syndrome " in " Plain Questions is led to and commented deficiency and excess opinion ", asthenia mostly occurs at congenital defect, lacks of proper care after one's birth, and serious disease prolonged illness, the patient of vital essence consumption wound.The course of disease is general longer, and symptom increases the weight of gradually, and short-term is rehabilitation not easily.Therapeutic effect and time, can the prosperity and decline of spleen kidney, remove pathogenesis, and whether obtain timely, correct treatment, nursing etc. because have substantial connection with the power of patient's body constitution.

For asthenia, especially frequently to pass out semen as the treatment of the deficiency of the kidney yin of mark, take tonification as basic principle.Say as " Plain Questions, three body parts and nine pulse-taking sites opinion ": " deficiency syndrome should be treated by tonifying method ".QI invigorating should be adopted respectively, nourish blood according to the difference of pathology attribute, the method for the treatment of of YIN nourishing, warming YANG, and in conjunction with the difference of diseases of five ZANG-organs position Selection drug, to strengthen the specific aim for the treatment of.

Doctor trained in Western medicine selects the calmness such as stable or chlordiazepoxide for the general treatment of pathological seminal emission, selects propantheline spasmolytic; Or suitably use estrogen, as diethyl stilbestrol treatment; But these methods can only respite seminal emission symptom, simultaneously large to the side effect of health.Although traditional Chinese medical science prescription can fundamentally tonification treatment, traditional Chinese medicine decocting, take loaded down with trivial details, treatment cycle is long, therefore, researches and develops and a kind ofly fast and effeciently treats the pharmaceutical composition that asthenia passes out semen and become those skilled in the art's problem demanding prompt solution.

Summary of the invention

The present invention is in order to solve above-mentioned deficiency, there is provided a kind of and treat pharmaceutical composition of asthenia seminal emission and preparation method thereof, described pharmaceutical composition composition is made up of following parts by weight: 10 ~ 30 parts, Radix Rehmanniae Preparata, Semen Ziziphi Spinosae 5 ~ 10 parts, Semen Coicis 5 ~ 10 parts, Fructus Corni 4 ~ 8 parts, Poria cum Radix Pini 2 ~ 6 parts, 5 ~ 10 parts, Poria, Radix Angelicae Sinensis 5 ~ 10 parts, the Radix Paeoniae Alba 5 ~ 10 parts, Chinese Magnoliavine 1 ~ 3 part, Semen Sinapis Albae 1 ~ 3 part, Cortex Cinnamomi 0.3 ~ 0.6 part, Rhizoma Coptidis 0.3 ~ 0.5 part, Halloysitum Rubrum 10 ~ 30 parts, Fructus Mume 5 ~ 10 parts, 5 ~ 10 parts, Semen Nelumbinis, Semen Ginkgo 4 ~ 8 parts, Rhizoma Curculiginis 2 ~ 6 parts, Fructus Alpiniae Oxyphyllae 5 ~ 10 parts, Fructus Psoraleae 5 ~ 10 parts, Rhizoma Drynariae 5 ~ 10 parts, Semen Juglandis 1 ~ 3 part, 1 ~ 3 part, Radix Glycyrrhizae, Fructus Rubi 0.3 ~ 0.6 part, Fructus Tritici Levis 0.3 ~ 0.5 part, the Radix Polygoni Multiflori 5 ~ 10 parts.

Wherein, in pharmaceutical composition, the component and effect of each component is:

Radix Rehmanniae Preparata sweet in the mouth, property are flat and enter blood system, function nourishing YIN and supplementing blood, vital essence replenishing and marrow benifiting.Control deficiency of YIN insufficiency of blood, the hollow institute of brains waist knee flaccidity, chronic cough hectic fever due to YIN-deficiency extremely, seminal emission, metrorrhagia, deafness, blurred vision, palpitation and insomnia, forgetful, night sweat etc.; Rhizoma Coptidis sweet in the mouth, slightly warm in nature, returns liver, spleen, lung, kidney channel, has effect that benefiting QI for strengthening the superficies, arresting sweating are admittedly de-, hold in the palm skin ulcer granulation promoting, inducing diuresis to remove edema; Radix Rehmanniae Preparata and Rhizoma Coptidis compatibility, be more suitable for yin-deficiency constitution crowd and use; Record in Shennong's Herbal, Semen Ziziphi Spinosae has " invigorating middle warmer the liver benefiting, hard muscles and bones, help the merit of cloudy gas ", for deficiency of YIN-blood, and severe palpitation, insomnia forgetfulness; The empty hyperhidrosis of body; Semen Coicis sweet in the mouth, light, cold nature, has invigorating spleen to remove dampness, clearing away heat and discharging pus function, can warming spleen and stomach for dispelling cold, benefiting vital QI and blood; The main tonifying kidney-yin of Fructus Corni, " book on Chinese herbal medicine newly organized " carries: " medicine of nourishing YIN does not have pieces of cloth, victor also only the large invigorating the liver and kidney of mountain cornel specially and not mix, both partially without cold and heat, again without the back of the body of negative and positive, reality is the hat of all nourishing YINs "; Semen Sinapis Albae master, except kidney pathogen, takes warming middle-JIAO for a long time; Poria cum Radix Pini removes heart-fire, peace tranquilizing mind, and controlling has a guilty conscience breathes hard; The Radix Polygoni Multiflori, Radix Angelicae Sinensis taste are admittedly very thick, specially enter Liver and kidney, take a tonic or nourishing food to build up one's health Kidney-Yin, fill out beneficial vital essence, have negative and positive and put down secret effect; The effect that " Traditional Chinese Medicine in Sichuan will " records Cortex cinnamomi japonici (Ramulus Cinnamomi) to be had " dispersing wind and cold, except arthralgia chiefly caused by damp pathogen, warms up waist knee joint, anti-nausea for liver and kidney tonifying, qualcomm meridian ", controls bones and muscles pain, the disease of the deficiency of YIN such as waist knee joint is existing cold; Fructus Schisandrae Chinensis, the Radix Paeoniae Alba have nourishing kidney, the effect of antiperspirant, arresting seminal emission of promoting the production of body fluid, receive, and control the disease of the body void such as xerostomia is done yearningly, spontaneous perspiration, night sweat, impairment caused by overstrain weakness and emaciation, emission.Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Fructus Rubi, Fructus Tritici Levis are astringency, prevent vital essence to run off, and Rhizoma Curculiginis, Semen Juglandis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae are the medicine of tonification, and subsidy yang-energy, specially controls asthenia, the Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription property of medicine.

According to another goal of the invention of the present invention, the invention provides a kind of preparation method for the treatment of the pharmaceutical composition of asthenia seminal emission, comprise the following steps:

Step S10, adopt liquid turbulence formula to extract after Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori, Radix Angelicae Sinensis mixing with adding ethanol, extracting solution is for subsequent use;

Step S11, by Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi and Fructus Tritici Levis with mix after add water and adopt liquid turbulence formula to extract, extracting solution is for subsequent use;

Step S12, merges the extracting solution obtained in the extracting solution obtained in step S10 and step S11, takes vacuum concentration to obtain drug extract thick paste;

Step S13, by Semen Ziziphi Spinosae, Semen Coicis and Fructus Corni crushed after being dried, with the drug extract thick paste combination drying of step S12 gained after mix homogeneously, obtains pharmaceutical composition solid;

Step S14, by the pharmaceutical composition solid of step S13 gained through pulverizing, adding adjuvant, granulating, making required dosage form.

Further, in step slo, the mixed extracting mode of described Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori and Radix Angelicae Sinensis is: the ethanol that medicinal material mixture adds 7 times ~ 12 times 77% ~ 84% is incubated and adopts liquid turbulence formula to extract after 3.5 hours ~ 4 hours under the condition of 71 DEG C ~ 84 DEG C.

Further, in step s 11, the mixed extracting mode of medicinal residues that described Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis and step S10 obtain is: adopt liquid turbulence formula to extract after the pure water that medicinal material mixture adds 7 times ~ 10 times is incubated 3 hours ~ 4 hours under the condition of 89 DEG C ~ 96 DEG C.

Further, in step s 12, the condition of described extracting solution vacuum concentration is: at 85kPa ~ 90kPa, concentrated under 60 DEG C ~ 70 DEG C conditions.

Further, in step s 12, described extracting solution is condensed into the thick paste that relative density is 1.30 ~ 1.38.

Further, in step s 13, the operation of described Semen Ziziphi Spinosae, Semen Coicis, Fructus Corni crushed after being dried is specially: pulverized 20 mesh sieves after above-mentioned medicinal material mixture naturally being dried.

Further, in step s 13, drug extract thick paste pulverize with Semen Ziziphi Spinosae, Semen Coicis, Fructus Corni after powder mix after dry condition be: under condition of normal pressure, 70 DEG C ~ 80 DEG C forced air dryings.

Further, in step S14, described pharmaceutical composition solid after crushed particle diameter is less than 50 μm.

Further, in step S14, the dosage form of described pharmaceutical composition is tablet or capsule or granule or soft capsule.

Advantage of the present invention is:

A kind of pharmaceutical composition and preparation method thereof for the treatment of asthenia seminal emission disclosed by the invention, for pure Chinese medicinal preparation, the basis of ancient prescription is revised, make curative effect more rapid, scientific formula is reasonable, and emphatically for deficiency of YIN medication, liquid turbulence formula is adopted to extract the effective ingredient of medicine, improve drug effect, adopt modern pharmaceutical technique to be prepared into the dosage form conveniently taken, be more beneficial to the treatment of patient.

Detailed description of the invention

Below provide specific embodiments of the invention, be used for being described in further detail the present invention.

Experimental technique in following embodiment, if no special instructions, is conventional method.Medicinal raw material used in following embodiment, reagent material etc., if no special instructions, be commercially available purchase product.

Embodiment 1

A kind of preparation for the treatment of the medicament composition granule agent of asthenia seminal emission

Crude drug forms: (unit: g)

Radix Rehmanniae Preparata 200, Semen Ziziphi Spinosae 75, Semen Coicis 75, Fructus Corni 60, Poria cum Radix Pini 40, Poria 75, Radix Angelicae Sinensis 75, the Radix Paeoniae Alba 75, Chinese Magnoliavine 2, Semen Sinapis Albae 2, Cortex Cinnamomi 4.5, Rhizoma Coptidis 4, Halloysitum Rubrum 20, Fructus Mume 75, Semen Nelumbinis 75, Semen Ginkgo 60, Rhizoma Curculiginis 40, Fructus Alpiniae Oxyphyllae 75, Fructus Psoraleae 75, Rhizoma Drynariae 75, Semen Juglandis 20, Radix Glycyrrhizae 20, Fructus Rubi 4.5, Fructus Tritici Levis 4, the Radix Polygoni Multiflori 75.

Prepare by the following method:

(1) 80.5% ethanol adding 3705g after getting Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori, Radix Angelicae Sinensis mixing adopts liquid turbulence formula to extract 4 hours under the condition of 78 DEG C, and filter, filtrate is for subsequent use.

(2) get Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis add 6kg pure water after mixing with (1) Chinese medicine slag adopts liquid turbulence formula to extract 3.5 hours under the condition of 90.5 DEG C, filter, filtrate is for subsequent use.

(3) above filtrate being merged, is 85kPa in vacuum, and temperature is condensed into the thick paste that relative density is 1.38 under 70 DEG C of conditions.

(4) 20 mesh sieves were pulverized, mix homogeneously after Semen Ziziphi Spinosae, Semen Coicis, Fructus Corni naturally being dried.

(5) by even for the medicament mixed after being pulverized and mixed in the thick paste in (3) and (4), under the condition of normal pressure 75 DEG C, forced air drying obtains pharmaceutical composition solid 374.4g.

(6) by aforementioned pharmaceutical compositions solid through micronizing, obtain the pharmaceutical composition powder 374.4g that particle diameter is less than 50 μm; According to drug powder: starch: the ratio of sucrose=6:3:1 adds starch 187.2g, sucrose 62.4g, mix homogeneously, granulate, make granule, subpackage, every bag of 4g, be total to obtain granule 156 bags.

Embodiment 2

A kind of preparation for the treatment of the medicinal composition tablets of asthenia seminal emission

Crude drug forms: (unit: g)

Radix Rehmanniae Preparata 100, Semen Ziziphi Spinosae 50, Semen Coicis 50, Fructus Corni 40, Poria cum Radix Pini 20, Poria 50, Radix Angelicae Sinensis 50, the Radix Paeoniae Alba 50, Chinese Magnoliavine 10, Semen Sinapis Albae 10, Cortex Cinnamomi 3, Rhizoma Coptidis 3, Halloysitum Rubrum 100, Fructus Mume 50, Semen Nelumbinis 50, Semen Ginkgo 40, Rhizoma Curculiginis 20, Fructus Alpiniae Oxyphyllae 50, Fructus Psoraleae 50, Rhizoma Drynariae 50, Semen Juglandis 10, Radix Glycyrrhizae 10, Fructus Rubi 3, Fructus Tritici Levis 3, the Radix Polygoni Multiflori 50.

Prepare by the following method:

(1) ethanol adding 1.54kg77% after getting Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori, Radix Angelicae Sinensis mixing adopts liquid turbulence formula to extract 3.5 hours under the condition of 71 DEG C, and filter, filtrate is for subsequent use.

(2) get Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis add 5474g pure water after mixing with (1) Chinese medicine slag adopts liquid turbulence formula to extract 3 hours under the condition of 89 DEG C, filter, filtrate is for subsequent use.

(3) above filtrate being merged, is 85kPa in vacuum, and temperature is condensed into the thick paste that relative density is 1.30 under 60 DEG C of conditions.

(5) by even for the medicament mixed after being pulverized and mixed in the thick paste in (3) and (4), under the condition of normal pressure 75 DEG C, forced air drying obtains pharmaceutical composition solid 257.3g.

(6) by aforementioned pharmaceutical compositions solid through micronizing, obtain the pharmaceutical composition powder 257.2g that particle diameter is less than 50 μm; Add 75% appropriate amount of ethanol, granulate, dry 1.5 hours with the temperature of 70 DEG C, after drying by medicinal mixture powder through tabletting machine process, every sheet 400mg, obtains medicine 643.

Embodiment 3

A kind of preparation for the treatment of the medicament composition capsule agent of asthenia seminal emission

Crude drug forms: (unit: kg)

Radix Rehmanniae Preparata 300, Semen Ziziphi Spinosae 100, Semen Coicis 100, Fructus Corni 80, Poria cum Radix Pini 60, Poria 100, Radix Angelicae Sinensis 100, the Radix Paeoniae Alba 100, Chinese Magnoliavine 30, Semen Sinapis Albae 30, Cortex Cinnamomi 6, Rhizoma Coptidis 5, Halloysitum Rubrum 300, Fructus Mume 100, Semen Nelumbinis 100, Semen Ginkgo 80, Rhizoma Curculiginis 60, Fructus Alpiniae Oxyphyllae 100, Fructus Psoraleae 100, Rhizoma Drynariae 100, Semen Juglandis 30, Radix Glycyrrhizae 30, Fructus Rubi 6, Fructus Tritici Levis 5, the Radix Polygoni Multiflori 100.

Prepare by the following method:

(1) 84% ethanol adding 672kg after getting Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori, Radix Angelicae Sinensis mixing adopts liquid turbulence formula to extract 4 hours under the condition of 84 DEG C, and filter, filtrate is for subsequent use.

(2) get Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis add 13820kg pure water after mixing with (1) Chinese medicine slag adopts liquid turbulence formula to extract 4 hours under the condition of 96 DEG C, filter, filtrate is for subsequent use.

(3) above filtrate being merged, is 90kPa in vacuum, and temperature is condensed into the thick paste that relative density is 1.38 under 70 DEG C of conditions.

(5) by even for the medicament mixed after being pulverized and mixed in the thick paste in (3) and (4), under the condition of normal pressure 80 DEG C, forced air drying obtains pharmaceutical composition solid 571.3kg.

(6) by aforementioned pharmaceutical compositions solid through micronizing; obtain the pharmaceutical composition powder 571.3kg that particle diameter is less than 50 μm; 70% appropriate amount of ethanol is added in pharmaceutical composition powder; dry 1 hour with the temperature of 60 DEG C after mixing thoroughly, granulate, dry 1.5 hours with the temperature of 70 DEG C; after drying; by medicinal powder mixture powder through the encapsulated process of granulator, every encapsulated 400mg, obtains capsule 1428250.

Embodiment 4

A kind of preparation for the treatment of the medicinal composition soft capsule agent of beriberi

Crude drug forms: (unit: kg)

Radix Rehmanniae Preparata 20, Semen Ziziphi Spinosae 7, Semen Coicis 8, Fructus Corni 6, Poria cum Radix Pini 5, Poria 9, Radix Angelicae Sinensis 8, the Radix Paeoniae Alba 7, Chinese Magnoliavine 2, Semen Sinapis Albae 2, Cortex Cinnamomi 0.5, Rhizoma Coptidis 0.4, Halloysitum Rubrum 20, Fructus Mume 7, Semen Nelumbinis 8, Semen Ginkgo 6, Rhizoma Curculiginis 5, Fructus Alpiniae Oxyphyllae 6, Fructus Psoraleae 7, Rhizoma Drynariae 8, Semen Juglandis 1, Radix Glycyrrhizae 2, Fructus Rubi 0.5, Fructus Tritici Levis 0.4, the Radix Polygoni Multiflori 7.

Prepare by the following method:

(1) ethanol adding 320kg81% after getting Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori, Radix Angelicae Sinensis mixing adopts liquid turbulence formula to extract 3.5 hours under the condition of 81 DEG C, and filter, filtrate is for subsequent use.

(2) get Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis add 780.3kg pure water after mixing with (1) Chinese medicine slag adopts liquid turbulence formula to extract 3.5 hours under the condition of 93 DEG C, filter, filtrate is for subsequent use.

(3) above filtrate being merged, is 87kPa in vacuum, and temperature is condensed into the thick paste that relative density is 1.35 under 65 DEG C of conditions.

(5) by even for the medicament mixed after being pulverized and mixed in the thick paste in (3) and (4), under the condition of normal pressure 75 DEG C, forced air drying obtains pharmaceutical composition solid 40.77kg.

(6) by aforementioned pharmaceutical compositions solid through micronizing, obtain the pharmaceutical composition powder 40.77kg that particle diameter is less than 50 μm, add Cera Flava, hydrogenated palm oil, soybean phospholipid fully stir, mix homogeneously, leaves standstill, evacuation, treat that in medicinal liquid, bubble is removed substantially, with the glue pelleting changed, every dress 380mg compacting, is total to obtain 200000.

experimental example 1

The animal acute toxicity test of Chinese medicine composition of the present invention

The present embodiment, by the mensuration of Mouse oral administration medicine median lethal dose(LD 50), has investigated the Chinese medicine composition of embodiment 2 preparation to the acute toxic reaction of mice and death condition.

Get mice 30, often organize 10, points 3 groups, be i.e. high, medium and low 3 dosage groups (0.8,0.4,0.2ml/15g) gastric infusion 3 times/day, the scope of prediction Calculating Median Lethal Dose of Drugs.Result shows, and high dose group does not measure median lethal dose(LD 50), therefore the mensuration of medicine gastric infusion median lethal dose(LD 50) is changed the mensuration doing maximum volume purgation maximum lane point-maximum tolerated dose.

Get mice 30, on an empty stomach after 12 hours, to predict selected 0.8ml/15g metering by only gastric infusion to animal subject 3 times/day, Continuous Observation 7 days.

Give in gavage and be subject to test product 24 hours, mice voluntary activity declines, and ingests, takes the photograph water minimizing; Within second day, voluntary activity is tending towards normal gradually, stool, urine no abnormality seen, and mice activity, food ration, body weight growth, feces etc. are all normal, observes test mice after expiring and all survives.

Observe after expiring and put to death whole test mice gross necropsy, find each important organ, after one's own heart, liver, spleen, lung, kidney, ovary, intestinal, stomach etc. change without obvious pathomorphism.

The maximum dosage-feeding result of the test of medicine gastric infusion shows: all without obvious toxic reaction after 30 mice administrations, also without dead in one week.Be 29.7g/kgd to recording maximum tolerated dose after mouse stomach administration medicine, as calculated by clinical one-tenth human oral dosage form 5.25g/60kg, the dosage being converted to mice is 0.6819g/kg, then the mice gavage maximum tolerated dose on the one of this medicine is 43.5 times [(29.7g/kg) ÷ (0.6819g/kg) ≈ 43.5] of clinical adult oral dose on the one.Illustrate that the safety of Chinese medicine composition of the present invention is good.

experimental example 2

In order to show that pharmaceutical composition that this treatment asthenia passes out semen is to the therapeutic effect of pathological seminal emission, the present invention is through 100 routine system clinical observations.The diagnostic criteria of passing out semen in Clinical Researches of New Drugs guideline in inclusive criteria reference: married man, existing normal sexuality person, but still have more seminal emission, or bachelor frequently passes out semen (1 time/1 ~ 3 day), with diseases such as dizzy, weak, the soreness of waist, continue more than 1 month person.Be divided into treatment group 50 example at random, matched group 50 example.The two suffers from age, the course of disease etc. through statistical procedures, no significant difference.Treatment group patient every day the oral embodiment of the present invention 1 finished product 12g, matched group propantheline every day sheet 30mg, 3 times/day, two groups of courses for the treatment of are 28 days, terminate to follow up a case by regular visits to 3 months evaluation curative effects the course for the treatment of.With reference to the criterion of therapeutical effect of passing out semen in new Chinese medicine guideline of clinical investigations.

The criterion of clinical therapeutic efficacy is:

Clinical cure: treat in latter 3 months, the person that has normal sexuality, no longer passes out semen; Without sexual life person, monthly seminal emission is less than 5 times, the transference cures such as giddy, tinnitus, forgetful, cardiopalmus, insomnia, the soreness of waist, lethargy.

Remarkable: to treat in latter 3 months, the person that has normal sexuality, monthly passes out semen 1 ~ 2 time; Without sexual life person, minimizing more than 2 times of passing out semen weekly, the cardinal symptoms such as giddy, tinnitus, the soreness of waist, lethargy disappear.

Effective: to treat in latter 3 months, the person that has normal sexuality, monthly passes out semen 2 ~ 3 times; Without sexual life person, minimizing more than 1 time of passing out semen weekly, the cardinal symptoms such as giddy, tinnitus, the soreness of waist, lethargy alleviate.

Invalid: unchanged before and after treatment

Clinical trial results:

The concrete condition of clinical trial results is in table 1

Table 1

Clinical trial results shows, after pharmaceutical composition one course for the treatment of using this treatment asthenia to pass out semen, has the patient of 72% to cure; The patient of 14% used through a course for the treatment of, and symptom is significantly improved; The patient of 10% used through a course for the treatment of, symptom improvement trend.

In a word, compared with the prior art, Chinese medicine composition of the present invention, prescription is simplified, but has the effect of the pathological seminal emission that significantly treatment deficiency of the kidney yin causes, and safety is better, takes more convenient.

These are only the preferred embodiments of the present invention and experimental example, be not limited to the present invention, for a person skilled in the art, the present invention can have various modifications and variations.Within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.

Claims

1. treat the pharmaceutical composition of asthenia seminal emission for one kind, it is characterized in that, described pharmaceutical composition composition is made up of following parts by weight: 10 parts ~ 30 parts, Radix Rehmanniae Preparata, Semen Ziziphi Spinosae 5 parts ~ 10 parts, Semen Coicis 5 parts ~ 10 parts, Fructus Corni 4 parts ~ 8 parts, Poria cum Radix Pini 2 parts ~ 6 parts, 5 parts ~ 10 parts, Poria, Radix Angelicae Sinensis 5 parts ~ 10 parts, the Radix Paeoniae Alba 5 parts ~ 10 parts, Chinese Magnoliavine 1 part ~ 3 parts, Semen Sinapis Albae 1 part ~ 3 parts, Cortex Cinnamomi 0.3 part ~ 0.6 part, Rhizoma Coptidis 0.3 part ~ 0.5 part, Halloysitum Rubrum 10 parts ~ 30 parts, Fructus Mume 5 parts ~ 10 parts, 5 parts ~ 10 parts, Semen Nelumbinis, Semen Ginkgo 4 parts ~ 8 parts, Rhizoma Curculiginis 2 parts ~ 6 parts, Fructus Alpiniae Oxyphyllae 5 parts ~ 10 parts, Fructus Psoraleae 5 parts ~ 10 parts, Rhizoma Drynariae 5 parts ~ 10 parts, Semen Juglandis 1 part ~ 3 parts, 1 part ~ 3 parts, Radix Glycyrrhizae, Fructus Rubi 0.3 part ~ 0.6 part, Fructus Tritici Levis 0.3 part ~ 0.5 part fleece-flower root 5 parts ~ 10 parts.

2. a preparation method for the pharmaceutical composition for the treatment of asthenia as claimed in claim 1 seminal emission, is characterized in that, comprise the following steps:

Step S10, adopt liquid turbulence formula to extract by adding ethanol after 10 parts ~ 30 parts, Radix Rehmanniae Preparata, Poria cum Radix Pini 2 parts ~ 6 parts, the Radix Polygoni Multiflori 5 parts ~ 10 parts and Radix Angelicae Sinensis 5 parts ~ 10 parts mixing, extracting solution is for subsequent use;

Step S11, adopt liquid turbulence formula to extract by adding water after 5 parts ~ 10 parts, Poria, the Radix Paeoniae Alba 5 parts ~ 10 parts, Chinese Magnoliavine 1 part ~ 3 parts, Semen Sinapis Albae 1 part ~ 3 parts, Cortex Cinnamomi 0.3 part ~ 0.6 part, Rhizoma Coptidis 0.3 part ~ 0.5 part, Halloysitum Rubrum 10 parts ~ 30 parts, Fructus Mume 5 parts ~ 10 parts, 5 parts ~ 10 parts, Semen Nelumbinis, Semen Ginkgo 4 parts ~ 8 parts, Rhizoma Curculiginis 2 parts ~ 6 parts, Fructus Alpiniae Oxyphyllae 5 parts ~ 10 parts, Fructus Psoraleae 5 parts ~ 10 parts, Rhizoma Drynariae 5 parts ~ 10 parts, Semen Juglandis 1 part ~ 3 parts, 1 part ~ 3 parts, Radix Glycyrrhizae, Fructus Rubi 0.3 part ~ 0.6 part and Fructus Tritici Levis 0.3 part ~ 0.5 part mixing, extracting solution is for subsequent use;

Step S12, by the extracting solution mixing obtained in the extracting solution obtained in step S10 and step S11, takes vacuum concentration to obtain concentrated solution;

Step S13, by Semen Ziziphi Spinosae 5 parts ~ 10 parts, Semen Coicis 5 parts ~ 10 parts and Fructus Corni 4 parts ~ 8 parts crushed after being dried, with the drug extract thick paste combination drying of step S12 gained after mix homogeneously, obtains pharmaceutical composition solid;

3. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step slo, the mixed extracting mode of described Radix Rehmanniae Preparata, Poria cum Radix Pini, the Radix Polygoni Multiflori and Radix Angelicae Sinensis is: the ethanol that medicinal material mixture adds 7 times ~ 12 times 77% ~ 84% is incubated and adopts liquid turbulence formula to extract after 3.5 hours ~ 4 hours under the condition of 71 DEG C ~ 84 DEG C.

4. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step s 11, the mixed extracting mode of medicinal residues that described Poria, the Radix Paeoniae Alba, Chinese Magnoliavine, Semen Sinapis Albae, Cortex Cinnamomi, Rhizoma Coptidis, Halloysitum Rubrum, Fructus Mume, Semen Nelumbinis, Semen Ginkgo, Rhizoma Curculiginis, Fructus Alpiniae Oxyphyllae, Fructus Psoraleae, Rhizoma Drynariae, Semen Juglandis, Radix Glycyrrhizae, Fructus Rubi, Fructus Tritici Levis and step S10 obtain is: adopt liquid turbulence formula to extract after the pure water that medicinal material mixture adds 7 times ~ 10 times is incubated 3 hours ~ 4 hours under the condition of 89 DEG C ~ 96 DEG C.

5. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step s 12, the condition of described extracting solution vacuum concentration is: concentrated under 85kPa ~ 90kPa, 60 DEG C ~ 70 DEG C conditions.

6. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 5, it is characterized in that, in step s 12, described extracting solution is condensed into the thick paste that relative density is 1.30 ~ 1.38.

7. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step s 13, the operation of described Semen Ziziphi Spinosae, Semen Coicis, Fructus Corni crushed after being dried is specially: pulverized 20 mesh sieves after above-mentioned medicinal material mixture naturally being dried.

8. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step s 13, drug extract thick paste pulverize with Semen Ziziphi Spinosae, Semen Coicis, Fructus Corni after powder mix after dry condition be: under condition of normal pressure, 70 DEG C ~ 80 DEG C forced air dryings.

9. the preparation method of the pharmaceutical composition for the treatment of asthenia seminal emission according to claim 2, it is characterized in that, in step S14, described pharmaceutical composition solid after crushed particle diameter is less than 50 μm.

10. the preparation method of the pharmaceutical composition for the treatment of asthenia according to claim 2 seminal emission, is characterized in that, in step S14, the dosage form of described pharmaceutical composition is tablet or capsule or granule or soft capsule.