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CN105796803A - Traditional Chinese medicine composition for treating and preventing prostatic diseases and its preparation method and use - Google Patents

Traditional Chinese medicine composition for treating and preventing prostatic diseases and its preparation method and use Download PDF

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Publication number
CN105796803A
CN105796803A CN201410836220.8A CN201410836220A CN105796803A CN 105796803 A CN105796803 A CN 105796803A CN 201410836220 A CN201410836220 A CN 201410836220A CN 105796803 A CN105796803 A CN 105796803A
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China
Prior art keywords
extract
lycopersici esculenti
saw palmetto
soybean
preparation
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Inventor
李集玉
孙婷
孙一婷
李丹宁
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Qingdao Jiayun Huahai Health Technology Co Ltd
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Qingdao Jiayun Huahai Health Technology Co Ltd
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Abstract

The invention relates to a medical product and a production method thereof and discloses a traditional Chinese medicine composition for treating and preventing prostatic diseases such as prostatic hyperplasia, prostatitis and prostatic cancer. The traditional Chinese medicine composition comprises sabal extract, soybean extract and tomato extract and can also comprise siraitia grosvenorii extract. The invention provides a preparation and a preparation method thereof. The traditional Chinese medicine composition can be used as a health product for treating prostatic diseases and greatly improves male living quality. The invention relates to the preparation method of the preparation. Though method improvement, ingredients produce synergism.

Description

A kind of Chinese medicine composition treating and preventing prostatosis and preparation thereof and application
Technical field
The present invention relates to medicinal preparation and production method thereof, it it is a kind of Chinese medicine composition treating and preventing the prostatosis such as prostatic hyperplasia, prostatitis, carcinoma of prostate, comprise Saw Palmetto P.E, soybean extract, Fructus Lycopersici esculenti extract, Fructus Momordicae extract can be contained, thering is provided its preparation and preparation technology thereof, said composition is particularly to being used for keep healthy prostate, raising male's quality of life simultaneously.
Background technology
Prostatosis is commonly encountered diseases and the frequently-occurring disease of male, common disease such as prostatitis, prostatic hyperplasia, carcinoma of prostate.Prostatitis is the commonly encountered diseases of Urology Surgery, accounts for first place in Urology Surgery male patient's the right side of fifty, shows as chronic, recurrent process more.Prostatitis main pathogenic is pathogenic infection, and pathogen invades prostate with urine, causes infecting.Pathological anatomy confirms that prostatitis pathological changes is typically limited to peripheral zone, and glandular tube is opened on Posterior urethral with uroflow vertical line is reverse herein, easily causes urine reflux, and central zone and transitional zone glandular tube trend are consistent with uroflow direction, are not susceptible to infect.Research also finds that prostate is not only had stimulation by the urate of urine, also precipitable one-tenth calculus, blocks glandular tube, as the protection place of antibacterial.These are it is found that illustrate the coexpress that prostatitis syndrome is multiple disease in fact, and complicated clinical manifestation is changeable, can produce various complication.
Additionally China has stepped into aging society, and prostatic hyperplasia is commonly encountered diseases and the frequently-occurring disease of elderly men.Cumulative many with population in the world senescence onset of illness.The sickness rate of prostatic hyperplasia was incremented by with the age, and cities and towns sickness rate is higher than rural area, and race difference also affects hyperplasia degree.Its symptom increases (especially night), dysuria with number of micturitions, uroflow attenuates as main feature.As climate change, fatigue, drink, the inducement such as sexual life or infection, very easily cause urine retention, even urine can not arranged completely, causes considerable distress.According to statistics, it is 70% that the elderly men sickness rate of more than 50 years old there are about the elderly men prostatic hyperplasia sickness rate in 30-50%, 70-90 year, and more than 80 years old there are about more than 90% suffers from this disease, domestic statistics, prostatic hyperplasia accounts for 8% the 11% of Urology Surgery inpatient.
Carcinoma of prostate refers to that generation is at prostatic epithelial malignancy.Within 2012, China's tumor registration area prostate-cancer incidence is 9.92/10 ten thousand, the 6th of row male malignancy sickness rate.Age of onset was in reduced levels before 55 years old, gradually rose after 55 years old, and sickness rate increases with advancing age, and the peak age is 70-80 year.Carcinoma of prostate is also kinds of tumor in western countries, and mortality rate is high..
Thus, prostatosis has become the commonly encountered diseases affecting men's health, annoyings many male, has severely impacted their quality of life, and prostatic health care has caused the extensive concern of society.So effectively preventing and treating the prostatosis such as prostatic hyperplasia, prostatitis, carcinoma of prostate, the prostatic product that keeps healthy has great social meaning, it will be greatly improved the quality of life of male.
Summary of the invention
The invention provides a kind of compositions treating and preventing prostatic hyperplasia, prostatitis, carcinoma of prostate, comprise Saw Palmetto P.E, Fructus Lycopersici esculenti extract, soybean extract, it is possible to containing Fructus Momordicae extract.Present invention also offers said composition preparation and its production and use.
The invention provides a kind of compositions, be used for treating and preventing prostatic hyperplasia, prostatitis, carcinoma of prostate, it is characterised in that it comprises following raw material: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part.It is preferred that Saw Palmetto P.E is 320 parts, Fructus Lycopersici esculenti extract is 50 parts, and soybean extract is 62.5 parts, and more preferably a compositions is containing Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg.
Present invention also offers a kind of compositions, it is characterized in that it comprises following raw material: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part, Fructus Momordicae extract 10-40 part can be contained, it is preferred that Saw Palmetto P.E is 600 parts, Fructus Lycopersici esculenti extract is 120 parts, soybean extract is 60 parts, Fructus Momordicae extract 20 parts, more preferably a compositions is containing Saw Palmetto P.E 600mg, Fructus Lycopersici esculenti extract 120mg, soybean extract 60mg, Fructus Momordicae extract 20mg.
Saw Palmetto P.E of the present invention is prepared gained by following methods:
After sabal raw material is cleaned, ambient ground;Cross 40-60 mesh sieve, weigh the sabal raw material pulverized in advance in extraction kettle, extraction kettle, separating still are respectively heated, reach to set extraction kettle 40 DEG C, the temperature that separating still is 25 DEG C, CO2 enters liquefaction tank liquor through gas purifier, extraction kettle squeezed into by preheated device, depurator, extraction kettle and separating still are boosted, after reaching required extraction kettle pressure 20MPa, separating still pressure 5MPa, closes dioxide bottle, start the cycle over extraction, collecting separating still discharging, dry to obtain Saw Palmetto P.E, in described Saw Palmetto P.E, content of fatty acid is 45%.
Fructus Lycopersici esculenti extract of the present invention is prepared gained by following methods:
Raw tomatoes material is pulled an oar, and squeeze and filter, it is dried by vacuum freezing effect, ambient ground, cross 20-40 mesh sieve, powder and hexane weight ratio (1:2) are put into extracting tank and forms intimate mixing, the dissolution from hexane of the pigment in raw material, separating hexane, the raw material of pretreatment enters extraction kettle;CO2 enters liquefaction tank liquor through gas purifier, then extraction kettle is squeezed into by the preheated device of high-pressure plunger pump, depurator, extraction kettle boosts to 30MPa and makes supercritical fluid, set separating still pressure 5MPa, CO2 enters liquefaction groove cycling extraction after device purified separating still, and extract is released from the bottom of separating still, collects separating still discharging, drying to obtain Fructus Lycopersici esculenti extract, in described Fructus Lycopersici esculenti extract, the content of lycopene is 10%.
Soybean extract of the present invention is prepared gained by following methods:
By Semen sojae atricolor ungrease treatment, with pulverizer, totally dry defatted soybean is pulverized, cross 20-40 mesh sieve, obtain coarse powder;Take and pulverize dry Semen sojae atricolor, add 70% ethanol (volume/weight) of 15 times amount, extract 1 hour 50 DEG C of room temperatures, filter, repeat 2 times, united extraction liquid, employing polyamide is chromatography media, and column chromatography is to extract refining, acetone extract eluent, dry extract, obtains soybean extract, and the content of described Isoflavone in Extract of Soybean is 40%.
Fructus Momordicae extract of the present invention is prepared gained by following methods:
First Fructus Momordicae fresh fruit is smashed to pieces, throw to extractor.Adding 3 times amount deionized waters for 1st time, heating, to boiling, is incubated 2h, starts timing from boiling, feed liquid is put into storage tank;Add 3 times amount deionized waters, ebuillition of heated for 2nd time, after insulation 2h, feed liquid is merged with the 1st feed liquid.Being poured into by the extracting solution of merging in concentrator and carry out concentrating under reduced pressure, temperature controls below 60 DEG C, and vacuum degree control, more than 0.08, is recycled to concentrated solution and raw material ratio when being 2.5:1, stops heating, release concentrated solution, cooling.Mateiral pump on microfiltration equipment is started, in concentrated solution suction tube type filter membrance, force (forcing) pump will be started, regulate pressure to 0.2MPa, collect the filtrate through tube type filter membrance, the solution to be concentrated water-dialyzing by 0.5 times will be added time complete, the dialysis solution being collected by, merging filtrate.The filtrate of collection is poured in the storage tank of ultrafiltration apparatus, open the force (forcing) pump of ultrafiltration apparatus, regulate pressure at 1MPa, filtrate retains, by passing through, the film that relative molecular mass is 40000, collect through filtrate, when filtrate is passed through less, slowly add the water-dialyzing of people 0.5 times, collect the dialysis filtrate passed through, merging filtrate.Filtrate being carried out spray drying, obtains Fructus Momordicae extract, in described Fructus Momordicae extract, mogroside content is 25%.
Present invention also offers a kind of composite preparation and preparation technology thereof, said preparation can effectively prevent and treat prostatic hyperplasia, prostatitis, carcinoma of prostate, and keep healthy prostate, thus being greatly improved the quality of life of male.
Preparation of the present invention is including but not limited to ordinary tablet, chewable tablet, buccal tablet, dispersible tablet, oral liquid, granule, powder, soft capsule, unguentum and tincture.
One of technical scheme is achieved like this: a kind of preparation, it is mainly composed of: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part.It is preferred that Saw Palmetto P.E is 320 parts, Fructus Lycopersici esculenti extract is 50 parts, and soybean extract is 62.5 parts, and more preferably a preparation main component is containing Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg.Preparation can contain the diluent of stabilizer and convention amount.Can select said preparation is soft capsule, and the content of above-mentioned soft capsule is mainly composed of: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part.It is preferred that Saw Palmetto P.E is 320 parts, Fructus Lycopersici esculenti extract is 50 parts, and soybean extract is 62.5 parts, and more preferably a soft capsule main component is containing Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg.Preparation can contain the diluent of stabilizer and convention amount.
The softgel shell of above-mentioned soft capsule by raw material weight percentage ratio can consist of the gelatin of 35% to 45%, 18% to 22% plasticizer, 0.08% to 0.11% preservative, 0 to 3% screening agent, the pigment of 0 to 1%, the correctives of 0 to 0.1% and surplus water.Above-mentioned plasticizer can be a kind of material in glycerol, sorbitol, sucrose or more than one mixture.Foregoing preservatives can be a kind of material in methyl hydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate or more than one mixture.
Above-mentioned screening agent can be a kind of material in titanium dioxide, barium sulfate, ferrum oxide, precipitated calcium carbonate or more than one mixture;Above-mentioned pigment can be lemon yellow, amaranth, carmine, cacao brown, white carbon black, light green, greyish purple in a kind of material or more than one mixing.Above-mentioned correctives can be a kind of material in bourbonal,ethyl vanillin, essential oil, Mentholum or more than one mixture.
Above-mentioned diluent can be a kind of material in Oleum Arachidis hypogaeae semen, Oleum Glycines, safflower oil, Oleum Hippophae, Oleum Camelliae, sabal oil, salad oil, Semen Maydis oil or more than one mixture.Aforementioned stable agent can be a kind of material in Cera Flava, phospholipid, Adeps caprae seu ovis, methylcellulose, ethyl cellulose, Polyethylene Glycol monostearate, glycerol or more than one mixture, and aforementioned stable agent can be a kind of material in tea polyphenols, tert-butylhydroquinone, Radix Glycyrrhizae antioxygen thing, Butylated hydroxyanisole, dibenzylatiooluene, propylgallate or more than one mixture.
The combinations thereof composition soft capsule preparation technology of the present invention is achieved like this: take the desired amount of Saw Palmetto P.E or diluent heating for dissolving stabilizer, stabilizer, adds the Fructus Lycopersici esculenti extract of requirement and stirs and make its emulsifying;Temperature controls, when 40 DEG C to 70 DEG C, add the soybean extract of requirement and stir, and adds the diluent of requirement, crosses colloid mill, obtains emulsion stable uniformly, standby;The capsule leather of above-mentioned soft capsule is standby: by the desired amount of water, plasticizer, preservative add have stirring decompressor interlayer stainless-steel pan in stir, as first liquid;Being joined by the desired amount of gelatin in the rustless steel jacketed pan filling first liquid, temperature controls constantly to reduce pressure stirring in room temperature, treats that gelatin grain expands post-heating and makes gelatin grain all melt and dissolved to 50-80 DEG C;Under stirring, add the desired amount of screening agent, pigment, continue decompression stirring 30-120 minute;Uniform melt and dissolved liquid filters, and by the compacting of filtrate insulation standing or the degassed stand-by above-mentioned soft capsule that reduces pressure: put into by capsule core material in liquid storage grain, uses rotating mould platen press compacting soft capsule;Then carry out washing ball, dry, be packaged to be present composition soft capsule.
Another technical scheme of the present invention is achieved like this: a kind of preparation, it is mainly composed of: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part, Fructus Momordicae extract 10-40 part, it is preferred that Saw Palmetto P.E is 600 parts, Fructus Lycopersici esculenti extract is 120 parts, soybean extract is 60 parts, Fructus Momordicae extract 20 parts, more preferably a preparation is containing Saw Palmetto P.E 600mg, Fructus Lycopersici esculenti extract 120mg, soybean extract 60mg, Fructus Momordicae extract 20mg.Preparation can contain the diluent of stabilizer and convention amount.Can select said preparation is powder, above-mentioned powder is mainly composed of: Saw Palmetto P.E 200-800 part, Fructus Lycopersici esculenti extract 30-180 part, soybean extract 30-90 part, Fructus Momordicae extract 10-40 part, it is preferred that Saw Palmetto P.E is 600 parts, Fructus Lycopersici esculenti extract is 120 parts, soybean extract is 60 parts, Fructus Momordicae extract 20 parts, more preferably a powder containing: Saw Palmetto P.E 600mg, Fructus Lycopersici esculenti extract 120mg, soybean extract 60mg, Fructus Momordicae extract 20mg, powder can contain the diluent of stabilizer and convention amount.
As required, with the Main Ingredients and Appearance of the content of above-mentioned soft capsule and capsule core material or powder and ratio thereof for foundation, the method that can produce the solid preparations such as tablet, granule, powder routinely obtains the solid dosage formss such as the tablet of the present invention, granule, powder, the method that can produce the liquid preparations such as oral liquid, injection, transfusion, Emulsion routinely obtains the liquid preparations such as the oral liquid of the present invention, injection, transfusion, Emulsion, and the method that can produce the semi-solid preparation such as unguentum, gel routinely obtains the semi-solid preparations such as the unguentum of the present invention, gel.
Present invention also offers said composition and preparation thereof and treat the purposes in prostatitic health food and food and medicine in preparation.
Present invention also offers said composition and preparation thereof the purposes in preparing the health food and food and medicine treating prostatic hyperplasia.
Present invention also offers said composition and preparation thereof the purposes in preparing the health food and food and medicine treating carcinoma of prostate.
Health food of the present invention, food, composite medicine are Saw Palmetto P.E, soybean extract, Fructus Lycopersici esculenti extract to be organically combined, it is possible to add Fructus Momordicae extract, regulate the physiological function of male comprehensively.The compatibility of raw material uses the effect having reached beyond thought Synergistic, provides a kind of new selection for health food and medicine.
Detailed description of the invention
By the examples below to present invention further instruction in addition, but do not limit the present invention in any form.
Embodiment 1
Take Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g add appropriate amount of starch, mixing, granule processed, 60 DEG C dry 6 hours, granulate, mistake 20 mesh sieves, subpackage 1000 bags, obtain granule of the present invention.
Embodiment 2
Taking Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate starch, mixing, granule processed, 60 DEG C dry 6 hours, and granulate is crossed 20 mesh sieves, is pressed into 1000, obtains ordinary tablet of the present invention.
Embodiment 3
Taking Saw Palmetto P.E 400g, Fructus Lycopersici esculenti extract 150g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate starch, mixing, granule processed, 60 DEG C dry 6 hours, and granulate is crossed 20 mesh sieves, is pressed into 1000, obtains ordinary tablet of the present invention.
Embodiment 4
Take Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate Fructus Citri tangerinae essence, sorbitol, starch, mixing, granule processed, 60 DEG C dry 6 hours, granulate, cross 20 mesh sieves, be pressed into 1000, obtain buccal tablet of the present invention.
Embodiment 5
Taking Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate starch, mixing, granule processed, 60 DEG C dry 6 hours, and granulate is crossed 20 mesh sieves, is pressed into 1000, obtains chewable tablet of the present invention.
Prepared by embodiment 6 oral liquid of the present invention
Take Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add white sugar, sorbic acid, stir evenly, filter, add water to 2000ml, embedding, sterilizing, to obtain final product.
Embodiment 7
Take Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate L-HPC, aspartame, starch, mixing, granule processed, 60 DEG C dry 6 hours, granulate, cross 20 mesh sieves, be pressed into 1000, obtain dispersible tablet.
Embodiment 8
Taking Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate starch, mixing, granule processed, 60 DEG C dry 6 hours, and granulate is crossed 20 mesh sieves, is pressed into 1000, to obtain final product.
Embodiment 9
Taking Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, add appropriate amount of starch, mixing, granule processed, 60 DEG C dry 6 hours, fill capsule, to obtain final product.
Embodiment 10
Take Saw Palmetto P.E 600g, Fructus Lycopersici esculenti extract 120g, soybean extract 60g, Fructus Momordicae extract 20g, mixed 40 mesh sieve secondaries, subpackage 1000 bags, and to obtain final product.
Embodiment 11
The softgel shell of soft capsule contains by weight percentage: the gelatin of 35%, the glycerol of 18%, the methyl parahydroxybenzoate of 0.08% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 9mg Cera Flava, the tert-butylhydroquinone (TBHQ) of 1mg, the safflower oil of surplus.
Embodiment 12
The softgel shell of soft capsule contains by weight percentage: the gelatin of 36%, the glycerol of 10%, the sorbitol of 10%, the ethylparaben of 0.10% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 13mg glycerol, surplus Oleum Glycines.
Embodiment 13
The softgel shell of soft capsule contains by weight percentage: the gelatin of 37%, the sorbitol of 22%, the methyl parahydroxybenzoate of 0.11, the lemon yellow of 0.35%, the ethyl vanillin of 0.07%, the water of the titanium dioxide surplus of 1%;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 45mg glycerol, the Polyethylene Glycol monostearate of 23mg, the Butylated hydroxyanisole (BHA) of 4mg, the salad oil of surplus.
Embodiment 14
The softgel shell of soft capsule contains by weight percentage: the gelatin of 38%, the sorbitol of 12%, the sucrose of 10%, the methyl parahydroxybenzoate of 0.08%, the propyl p-hydroxybenzoate of 0.02%, the amaranth of 0.1%, the barium sulfate of 0.5% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 9mg tween 80, the tert-butylhydroquinone (TBHQ) of 6mg, the Semen Maydis oil of surplus.
Embodiment 15
The softgel shell of soft capsule contains by weight percentage: the gelatin of 39%, the glycerol of 19.5%, the methyl parahydroxybenzoate of 0.08%, the propyl p-hydroxybenzoate of 0.02%, 0.2% greyish purple, the ground calcium carbonate of 3% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, the Caulis et Folium Brassicae capitatae of surplus.
Embodiment 16
The softgel shell of soft capsule contains by weight percentage: the gelatin of 40%, the glycerol of 21%, the ethylparaben of 0.09%, the cacao brown of 0.28%, the titanium dioxide of 0.06%, the ferrum oxide of 0.68% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 6mg propylgallate (PG), the Oleum Hippophae of surplus.
Embodiment 17
The softgel shell of soft capsule contains by weight percentage: the gelatin of 41%, the glycerol of 15%, the sucrose of 3%, the butyl p-hydroxybenzoate of 0.1%, the cacao brown of 0.12, the essential oil of 0.01% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, the salad oil of surplus.
Embodiment 18
The softgel shell of soft capsule contains by weight percentage: the gelatin of 42%, the glycerol of 21%, the methyl parahydroxybenzoate of 0.08%, the propyl p-hydroxybenzoate of 0.02%, 0.28% light green, the titanium dioxide of 0.8% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, the safflower oil of surplus.
Embodiment 19
The softgel shell of soft capsule contains by weight percentage: the gelatin of 43%, the glycerol of 20%, the ethylparaben of 0.1%, 0.2% light green, the barium sulfate of 0.75% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 5mg Butylated hydroxyanisole (BHA), the propylgallate (PG) of 4mg, the Oleum Glycines of surplus.
Embodiment 20
The softgel shell of soft capsule contains by weight percentage: the gelatin of 44%, the glycerol of 22%, the butyl p-hydroxybenzoate of 0.08%, the white carbon black of 0.18%, the titanium dioxide of 0.65% and the water of surplus;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 5mg Licorice root antioxidant, the dibenzylatiooluene (BHT) of 4mg, the Caulis et Folium Brassicae capitatae of surplus.
Embodiment 21
The softgel shell of soft capsule contains by weight percentage: the gelatin of 45%, the glycerol of 18%, the water of the greyish purple and surplus of 0.1%;The capsule core material of this soft capsule contains: Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg, 5mg glycerol, the safflower oil of surplus.
The preparation of above-described embodiment gained can by following it have been experienced that its performance:
Test example 1 prostatic hyperplasia is tested
The male cleaning grade SD rat of laboratory animal 7 week old, weight 200~250g, raising temperature 23 DEG C ± 2 DEG C, lighting hours 12h/d (7: 00~19: 00), adaptability is tested after raising one week.
Reagent proscar is purchased from Hangzhou Mo Shadong pharmaceutical Co. Ltd;Testosterone propionate is purchased from Tianjin KingYork Amino Acid Co., Ltd.
50 rats are randomly divided into 5 groups by medication: Normal group, model control group, proscar 19.5mg/kg group, compositions 250,500mg/kg group.Except Normal group, other are the group testosterone propionate (7.5mg/Kg) that subcutaneous injection dissolves with olive oil respectively respectively, continuous 12d, Normal group injection olive oil solution, gastric infusion after every day subcutaneous injection 30min, Normal group and model group such as give at the distilled water of capacity, and after last administration, 24h weighs execution on an empty stomach.
The mensuration mice etherization of serum testosterone (T), Culling heart blood, it is placed in the centrifuge tube that heparin processed with the centrifugal 5min of 5000r/min, separated plasma, measures for level of serum testosterone.Serum testosterone adopts liquid equilibrium competition radio immunoassay to measure.125Binding site on I labelled antigen Ag competition limitation antibody A b.In sample, the concentration of Ag and Ag-Ab complex are the functional relationship of negative correlation, and show on dose-effect curve, with this curve for according to can sample be carried out quantitatively.Separating medium is for free phase and the separation in conjunction with phase.Computing formula is (standard pipe cpm value-NSB pipe cpm value)/(zero standard pipe cpm value-NSB pipe cpm value)
The compositions impact on prostatic hyperplasia
Compare with model group, * P < 0.05, * * P < 0.01
Result is compared with Normal group, and model group mouse prostate weight in wet base and prostate index substantially increase, and level of serum testosterone significantly raises, and modeling success is described.Bring out compared with mouse prostate model of hyperplasia group with Testosterone Propionate, compositions heavy dose group can substantially reduce mouse prostate weight and prostate index (P < 0.01).Additionally, the large and small dosage group of compositions extract can improve the rising of mice serum testosterone levels significantly, and present certain dose-effect relationship.
Test example 2 carrageenan-induced rat prostatitis is tested
The male cleaning grade SD rat of laboratory animal 7 week old, weight 200~250g, raising temperature 23 DEG C ± 2 DEG C, lighting hours 12h/d (7: 00~19: 00), adaptability is tested after raising one week.
Reagent QIANLIEKANG, purchased from Zhejiang Kang Enbei pharmaceutical Co. Ltd;Carrageenin, for SIG-MA Products
50 rats are randomly divided into 5 groups by medication: Normal group, model control group, QIANLIEKANG 500mg/kg group, compositions 250,500mg/kg group.Compositions high and low dose group and QIANLIEKANG administration group rat with 10mg/kg gavage, 1 time/d, continuous 9d.Normal group and model control group give isometric(al) aqueous solution.Carry out after 7th administration 1h anaesthetizing and aseptic operation operation: 3% pentobarbital sodium is with after 1.5mg/kg intraperitoneal injection of anesthesia rat, at hypogastrium median incision 1cm under aseptic condition, it is proposed to bladder and both sides seminal vesicle, exposes the prostate notopodium invested inside seminal vesicle.1% carrageenin with 0.2 μm of filter membrane sterilizing is injected separately in prostate bilateral notopodium with the dosage of 0.1ml/, then bladder is resetted and layer-by-layer suture.Post operation continues gavage 2d, after last administration 1h, is put to death by animal and measures prostatitis index.
The determination experiment animal of leukocyte (WBC) sum and lecithin density wins prostate after etherization, accurately weighs 50mg and adds 200 μ L physiology salt, 200 order net filtrations after grinding in manual glass homogenizer.Eddy mixer after fully mixing take 20 μ L, adds 380 μ L leukocyte diluents, under optical microscope, count leukocyte count and observe lecithin density.Measuring and be divided into 4 grades by Clinical Laboratory Standards, namely expiring the visual field is 4 grades, and 3/4 visual field is 3 grades, and 1/2 visual field is 2 grades, and 1/4 visual field is 1 grade.
Prostatic fraction of serum acid phosphatase determination of activity, by rat under etherization Culling heart blood and after standing 1h, separates serum with the centrifugal 15min of 3000r/min under 4 DEG C of conditions and measures prostate acid phosphatase activity in serum.β prostatic fraction of serum acid phosphatase activity uses prostate acid phosphatase testing cassete to measure.
Zn content measure by 10% prostata tissue homogenate 4 DEG C with the centrifugal 10min of 3000r/min after, after taking homogenate supernatant distilled water diluting 10 times, use TAS-990 atomic absorption spectrophotometer to detect and adopt standard curve method to calculate the Zn content in prostata tissue homogenate.
The mensuration of prostata tissue malonaldehyde (MDA) level takes prostata tissue, makes the tissue homogenate of 10% with 0.9% normal saline, and 12000r/min is centrifuged 15min, after, supernatant is for the mensuration of MDA level.Utilize the malonaldehyde (MDA) in lipid peroxide catabolite can form red product with thiobarbituricacidα-condensation, have the character of maximum absorption band at 532nm place, be measured by thiobarbituric acid reaction thing (TBARS) colorimetry.
The mensuration of prostata tissue ORAC (ORAC) adds phosphate buffer in 96 orifice plates, add 6% perchloric acid Deproteinization blood plasma 20 μ L again, then AAPH140 μ L and buffer 20 μ L it is sequentially added into, add 20 μ Ldisodiumfluorescein and start reaction, 96 orifice plates are placed in the fluorescence microplate reader that temperature conditions is 37 DEG C are measured rapidly.Its principle be fluorescent material disodiumfluorescein under 485nm light excites, launch 527nm fluorescence, it is possible to by can be discharged peroxy radical AAPH oxidation and make fluorescent characteristic disappear.When antioxidant exists, with disodiumfluorescein competitive oxidation agent, the speed that its fluorescence disappears can be slowed down.According to this characteristic, sample oxygen radical removing activity can be measured.
In blood plasma, the mensuration of NO level adopts Griess reagent color developing method to measure serum NO level- 3/NO- 2Content represent the concentration of serum NO level.Take 10% tissue homogenate sample of 40 μ l, add Griess reagent (0.05% naphthodiamide of 160 μ l, stand 20min, 550nm wavelength after 0.5% sulfanilamide and 2.5% phosphoric acid 2 and measure solution optical density value (OD) value, calculate NO content according to NO standard curve.The sodium nitrite PBS solution 40 μ l of variable concentrations is added in 160 μ lGriess reagent by being prepared by of NO standard curve, mixing, and after standing 20min, 550nm wavelength measures solution optical density value (OD).With sodium nitrite for abscissa, surveyed OD value is vertical coordinate, makes (NO-)-OD standard curve.
Statistical procedures experimental data represents with x ± s, carries out statistical procedures with Studentt-test inspection, and P < 0.05 is statistically significant.
Carrageenan-induced rat prostatitis test (x ± s, n=10)
Note: compare with matched group, #P < 0.05, ##P < 0.01;Compare with model group, * P < 0.05, * * P < 0.01
It is as shown in the table for result, and compared with carrageenan-induced rat prostatitis model group, high and low dose compositions significantly improves lecithin density in rat prostate liquid (P < 0.01), reduces leukocyte (WBC) sum.When inquiring into prostate acid phosphatase activity change in Zn content and serum in prostata tissue homogenate, it has been found that carrageenin can substantially increase prostatic fraction of serum acid phosphatase activity in substantially reducing prostata tissue while Zn content.Compositions can be effectively improved Zn content in rat prostate tissue, is obviously improved prostatic fraction of serum acid phosphatase activity, and presents certain dose-effect relationship.Inquiring into compositions confirming when affecting rat blood serum and prostata tissue oxidative stress status, compared with model group, compositions can effectively reduce rat blood serum and prostata tissue MDA level, alleviate the rat prostate tissue ORAC ORAC level decline that carrageenin causes, and there is certain dose-effect relationship.
Test example 3 anti-prostate cancer is tested
Anti-prostate cancer test adopts the MIT method of antitumor drug experimental technique, takes the stable human prostata cancer PC-3 cell of Secondary Culture and adjusts through counting, cell density 1 × 105/ ml, is inoculated in 96 well culture plates, every porocyte suspension 200 μ l, CO2To compositions intervention after cultivation 24h in incubator. group technology: 0.25mg/ml, 0.50mg/ml, 1.00mg/ml, 2.00mg/ml, 4.00mg/ml5 concentration combination thing group is set according to composition concentration, and PC-3 cell controls group is set, often organize each 5 repeating holes.Continue to cultivate 48h, MMT method microplate reader 492nm wavelength after adding compositions and measure cell viability (proliferation inhibition rate computing formula: (compositions group, matched group OD value all deduct the OD value correction of zeroing hole in cell proliferation inhibition rate=matched group OD value-compositions group OD value/matched group OD value × 100%..
Concentration (mg/ml) OD value Suppression ratio (%)
0.25 0.422±0.011 32.8
0.50 0.364±0.012 38.7
1.00 0.211±0.011 66.5
2.00 0.092±0.007 86.4
4.00 0.023±0.006 96.5
Result shows, compositions all suppresses proliferation of human prostate carcinoma PC-3 cell with dosage-dependent manner, proliferation inhibition rate increases with compositions liquor strength and increases, when compositions same concentrations, the inhibitory action of prostate cancer cell proliferation is compared, difference statistically significant (P < 0.01)
Test example 4 clinical observation material
Clinical observation, adult takes the compositions of the present invention, accidental gastrointestinal upset person, does not generally affect continual cure.The total effective rate of compositions treatment prostatitis 200 example of the present invention is 96.3%, clinical observation is evident in efficacy to the improvement of its main disease, effective percentage such as pudendum distending pain, lower abdomen contracture, waist dull pain and dribbling urination, puckery pain all reaches more than 90%, compare with matched group, significant difference (P < 0.01);To prostate local sign curative effect, the effective percentage of as firmly tough in body of gland and tenderness respectively 71.7% and 91.8%, hence it is evident that be better than matched group, two groups of comparing differences notable (P < 0.01);Reduce prostatic fluid leukocyte count, increase lecithin aspect, compositions group effective percentage respectively 95.0% and 92.8%, matched group respectively 58.9% and 56.1%, the two comparing difference notable (P < 0.01);In prostate ultrasound diagnosis, compositions group effective percentage is substantially better than matched group, and two groups are compared, significant difference (P < 0.01).
Compositions treatment prostatic hyperplasia 150 example of the present invention, overall clinical efficacy rate reaches 87.4%, to improving that main disease such as the nocturia frequency, the sound of rain pattering of prostatic hyperplasia are clean, urinate not the total effective rate such as smooth, difficulty and pain in micturition all more than 85.0%, it is substantially better than matched group, two groups of contrast differences notable (P < 0.01);Prostate local sign such as prostate increases, matter is hard, tough, the curative effect of disappearence of central groove, composition component is not 42.2%, 54.7%, 52.2%, matched group respectively 23.2%, 19.7%, 21.8%, compositions group is substantially better than matched group, two groups are compared, significant difference (P < 0.01);Prostate ultrasound diagnosis result, in prostate size, residual urine volume aspect, treatment group curative effect is superior to matched group, and significant difference (P < 0.01), each parameter value results contrast of urinary flow before and after two groups of treatments, in Qmax, AFR, compositions group is superior to matched group, the two comparing difference notable (P < 0.01).From clinical test results, the compositions treatment prostatitis of the present invention, prostatic hyperplasia show that its curative effect is comparatively satisfied.

Claims (10)

1. the compositions treating and preventing prostatosis, it is characterised in that it comprises the raw material of following weight: Saw Palmetto P.E 200~800 parts, Fructus Lycopersici esculenti extract 30~180 parts, soybean extract 30~90 parts.
2. compositions according to claim 1, it is characterised in that: compositions also comprises Fructus Momordicae extract 10-40 part.
3. compositions according to claim 2, it is characterized in that: Saw Palmetto P.E is 600 parts, Fructus Lycopersici esculenti extract is 120 parts, soybean extract is 60 parts, Fructus Momordicae extract 20 parts, it is preferable that it is 600mg that a compositions contains Saw Palmetto P.E, and Fructus Lycopersici esculenti extract is 120mg, soybean extract is 60mg, Fructus Momordicae extract 20mg.
4. compositions according to claim 1, it is characterized in that: Saw Palmetto P.E is 320 parts, Fructus Lycopersici esculenti extract is 50 parts, and soybean extract is 62.5 parts, it is preferable that a compositions contains Saw Palmetto P.E 320mg, Fructus Lycopersici esculenti extract 50mg, soybean extract 62.5mg.
5. compositions according to claim 1, it is characterised in that: described Saw Palmetto P.E is prepared gained by following methods, after sabal raw material is cleaned, ambient ground;Cross 40-60 mesh sieve, weigh the sabal raw material pulverized in advance in extraction kettle, extraction kettle, separating still are respectively heated, reach to set extraction kettle 40 DEG C, the temperature that separating still is 25 DEG C, CO2 enters liquefaction tank liquor through gas purifier, extraction kettle squeezed into by preheated device, depurator, extraction kettle and separating still are boosted, after reaching required extraction kettle pressure 20MPa, separating still pressure 5MPa, closes dioxide bottle, start the cycle over extraction, collecting separating still discharging, dry to obtain Saw Palmetto P.E, in described Saw Palmetto P.E, content of fatty acid is 45%.
6. compositions according to claim 1, it is characterized in that: described Fructus Lycopersici esculenti extract is prepared gained by following methods, raw tomatoes material is pulled an oar, and squeeze and filter, it is dried by vacuum freezing effect, ambient ground, cross 20-40 mesh sieve, powder and hexane weight ratio (1:2) are put into extracting tank and forms intimate mixing, the dissolution from hexane of the pigment in raw material, separating hexane, the raw material of pretreatment enters extraction kettle;CO2 enters liquefaction tank liquor through gas purifier, then extraction kettle is squeezed into by the preheated device of high-pressure plunger pump, depurator, extraction kettle boosts to 30MPa and makes supercritical fluid, set separating still pressure 5MPa, CO2 enters liquefaction groove cycling extraction after device purified separating still, and extract is released from the bottom of separating still, collects separating still discharging, drying to obtain Fructus Lycopersici esculenti extract, in described Fructus Lycopersici esculenti extract, the content of lycopene is 10%.
7. compositions according to claim 1, it is characterised in that described soybean extract is prepared gained by following methods, by Semen sojae atricolor ungrease treatment, pulverizes totally dry defatted soybean with pulverizer, crosses 20-40 mesh sieve, obtain coarse powder;Take and pulverize dry Semen sojae atricolor, add 70% ethanol (volume/weight) of 15 times amount, extract 1 hour 50 DEG C of room temperatures, filter, repeat 2 times, united extraction liquid, employing polyamide is chromatography media, and column chromatography is to extract refining, acetone extract eluent, dry extract, obtains soybean extract, and the content of described Isoflavone in Extract of Soybean is 40%.
8. compositions according to claim 1, it is characterised in that described Fructus Momordicae extract is prepared gained by following methods: first smashed to pieces by Fructus Momordicae fresh fruit, throws to extractor.Adding 3 times amount deionized waters for 1st time, heating, to boiling, is incubated 2h, starts timing from boiling, feed liquid is put into storage tank;Add 3 times amount deionized waters, ebuillition of heated for 2nd time, after insulation 2h, feed liquid is merged with the 1st feed liquid.Being poured into by the extracting solution of merging in concentrator and carry out concentrating under reduced pressure, temperature controls below 60 DEG C, and vacuum degree control, more than 0.08, is recycled to concentrated solution and raw material ratio when being 2.5:1, stops heating, release concentrated solution, cooling.Mateiral pump on microfiltration equipment is started, in concentrated solution suction tube type filter membrance, force (forcing) pump will be started, regulate pressure to 0.2MPa, collect the filtrate through tube type filter membrance, the solution to be concentrated water-dialyzing by 0.5 times will be added time complete, the dialysis solution being collected by, merging filtrate.The filtrate of collection is poured in the storage tank of ultrafiltration apparatus, open the force (forcing) pump of ultrafiltration apparatus, regulate pressure at 1MPa, filtrate retains, by passing through, the film that relative molecular mass is 40000, collect through filtrate, when filtrate is passed through less, slowly add the water-dialyzing of people 0.5 times, collect the dialysis filtrate passed through, merging filtrate.Filtrate being carried out spray drying, obtains Fructus Momordicae extract, in described Fructus Momordicae extract, mogroside content is 25%.
9. the compositions according to claim 1 purposes in preparation treatment prostatic hyperplasia, prostatitis, prostate cancer disease preparation.
10. the preparation that prepared by compositions according to claim 1, it is characterised in that described preparation is ordinary tablet, chewable tablet, buccal tablet, dispersible tablet, oral liquid, granule, powder, soft capsule, hard capsule, unguentum and tincture.
CN201410836220.8A 2014-12-30 2014-12-30 Traditional Chinese medicine composition for treating and preventing prostatic diseases and its preparation method and use Pending CN105796803A (en)

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