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CN106668329A - Botanical formula for treatment of benign prostatic hyperplasia and preparation method thereof - Google Patents

Botanical formula for treatment of benign prostatic hyperplasia and preparation method thereof Download PDF

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Publication number
CN106668329A
CN106668329A CN201610973118.1A CN201610973118A CN106668329A CN 106668329 A CN106668329 A CN 106668329A CN 201610973118 A CN201610973118 A CN 201610973118A CN 106668329 A CN106668329 A CN 106668329A
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parts
prescription
herba
radix
prostatic hyperplasia
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不公告发明人
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Kunming Wo Lin Biological Engineering Co Ltd
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Kunming Wo Lin Biological Engineering Co Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56—Materials from animals other than mammals
    • A61K35/63—Arthropods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/288—Taraxacum (dandelion)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/346—Platycodon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/537—Salvia (sage)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/78—Saururaceae (Lizard's-tail family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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    • A61K2236/30—Extraction of the material
    • A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention relates to a botanical formula for the treatment of benign prostatic hyperplasia and a preparation method thereof. More specifically, the invention relates to the technical field of traditional Chinese medicine and especially belongs to a black tea and traditional Chinese medicine formula for the treatment of benign prostatic hyperplasia. The formula contains bee pollen, dandelion, purslane, Houttuynia, radix platycodi, Poria, peach kernel, black tea, salviae miltiorrhizae and pseudo-ginseng. The invention also relates to a method for preparing the formula, a solid preparation containing the formula, and application of the formula in the preparation of the solid preparation such as medicinal tea, powder, granules, etc. for treatment of benign prostatic hyperplasia. The formula of the invention has excellent characteristics as described in the specification.

Description

It is a kind of to treat plant prescription of benign prostatic hyperplasia and preparation method thereof
Technical field
The present invention relates to a kind of treat plant prescription of benign prostatic hyperplasia and preparation method thereof, it is related to traditional Chinese medicine technology Field, especially belongs to a kind of black tea and Chinese prescription for treating benign prostatic hyperplasia.
Background technology
Benign prostate hyperplasia（Benign prostatic hyperplasia BPH) it is person in middle and old age（With more than 50 years old Based on）Common, the multiple diseases of urinary system of male, is the commonly encountered diseases therefore of elderly men lower urinary tract obstruction, with Progressive dysuria is major clinical feature.
The clinical manifestation of BPH has the irritations sign of bladder such as frequent micturition, urgent micturition；The obstructions such as urine line attenuates, nocturia；It is little The other symptoms such as abdomen or perineal position distending pain, bearing down, lumbago, and the related complication such as the acute urinary retention by caused by BPH.
BPH has a strong impact on physically and mentally healthy and quality of life, its social influence for causing and the economy of elderly men Burden is noticeable.The sickness rate of BPH increasingly increases, and relevant information shows, 40 years old former sickness rate of male is very low, 50 years old man More than 50%, male's sickness rate will be up to 90% to property BPH sickness rate within 80 years old.
Chinese medicine thinks that benign prostate hyperplasia belongs to Chinese medicine " difficulty in urination ", the category of " essence is infirmity ".Its etiology and pathogenesis is " kidney deficiency blood is tired ", " kidney deficiency ", " blood is tired " are the two big key factors for causing prostate gland paraplasm.Hyperplasia of prostate is The card of deficiency in origin and excess in superficiality, deficiency of kidney-QI is this, and blood addiction, damp and hot etc. are mark, and pathology key is at " kidney deficiency blood is tired ".Kidney qi virtual loss and addiction blood hinder Stagnant is two most important factors that BPH occurs." blood addiction " is the key factor of BPH morbidities；" kidney deficiency " is the basic of BPH morbidities Reason." kidney deficiency blood is tired " collective effect, makes prostatic hyperplasia that progressive is presented with the growth at age and increases.And kidney qi is weak, The process of prostatic hyperplasia is accelerated again, and the touching difficulty for ultimately resulting in primary disease heals.
Although Modern medical therapy BPH methods are more, uncertain therapeutic efficacy determine, treatment time is long, once and be discontinued, relapse rate Height, side effect is larger, and long-term taking will also result in larger infringement to hepatic and renal function；Chinese medicine have accumulated in the treatment of primary disease Rich experience, there is its distinctive feature, satisfactory effect, but lacks the diagnostic and therapeutic system and relevant criterion of specification.Chinese medicine has overall tune Section is acted on, can be in multisystem, too many levels adjustment whole body function.The suitable clearing away damp-heat of excess syndrome, dissipating blood stasis knot, promoting the circulation of QI machine and waterway；It is empty Card is preferably mended. spleen kidney, gasification is helped, and make urine certainly logical.Jing after Chinese medicine active treatment, patient clinical symptom is can obviously improve.Chinese medicine BPH is with low cost for treatment, determined curative effect, untoward reaction are few.In recent years, Chinese medicine field have developed many and has before improvement in succession The new formula of Chinese herbal medicine of row gland hypertrophy effect, some of them prescription is to adopt to make capsule, tablet and health care medicinal The mode of tea etc. is administered, and obtains certain curative effect, but the product of existing market these treatment prostatic hyperplasias on sale is special It is that health care tea product also there are in actual use many problems：（1）The curative effect of health tea is single, most all simply to change It is apt to one to two kinds of symptoms, not with therapeutic；（2）Each product all has certain side effect, and therapeutic effect is not notable； （3）Costly, ordinary consumer is not easily accepted by price.
The Chinese patent of Application No. 200810114218.4 disclose it is a kind of by Ramulus Cinnamomi, Poria, Semen Persicae, Cortex Moutan, the Radix Paeoniae Alba, The Chinese medicine compound of Brassica campestris L pollen Six-element Chinese medicine composition, each component coordinative role is not notable, is not reaching to treating both the principal and secondary aspects of a disease, cures the disease strong The effect of body.
The Chinese patent of Application No. 200810167505.1 disclose it is a kind of by Fructus Mori, Semen Euryaless, Mian Rhizoma Dioscoreae Septemlobae, Fructus Rosae Laevigatae, Fructus Gardeniae, the Chinese medicine preparation of Pollen Brassicae campestriss Six-element Chinese medicine composition, it is without functions such as promoting blood circulation, eliminating stagnations, and it is double empty, wet that it is mainly used in spleen kidney The prostatosis of hot-fluid note, scope of medication is narrower.
The content of the invention
The purpose of the present invention is exactly in order to solve the above problems, from vegetable kingdom --- and the pure natural in beautiful Yunnan is planted Thing, according to《The southern regions of the Yunnan Province book on Chinese herbal medicine》And Minorities in Yunnan folk tradition secret recipe, Jing scientific allocations, with modern processing it is refined and Into.Selected plant bee pollen, Herba Portulacae, Herba Taraxaci etc. have heat clearing and inflammation relieving, scattered stasis detumescence, the raw material of inducing diuresis for treating stranguria syndrome, to treatment Prostatosis have important breakthrough, especially evident in efficacy to prostatitis and hypertrophy, definite, stable, lasting, thorough, safe, far Better than it is existing treatment prostatosis medicine, and cure after the state of an illness not repeatedly.Major function：Blood circulation promoting and blood stasis dispelling, heat clearing and inflammation relieving, Dehumidification swelling, tonneau bladder.A kind of plant prescription for treating benign prostatic hyperplasia, the plant group are provided according to Chinese medical theory The characteristics of side is according to benign prostatic hyperplasia is thought in theory of Chinese medical science, is increased by summarizing many decades clinical treatment benign prostate Science is extracted and formed on the basis of raw experience, and product Jing in clinical 90 patients is observed for a long time, it was demonstrated that its evident in efficacy, nothing Any toxic and side effects.
The present invention also aims to provide the preparation method of the prescription.
A kind of prescription of the present invention, its include bee pollen, Herba Taraxaci, Herba Portulacae, Herba Houttuyniae, Radix Platycodoniss, Poria, Semen Persicae, Black tea, Radix Salviae Miltiorrhizae and Radix Notoginseng.
The prescription of present invention treatment, it is characterised in that by the raw material of following proportioning（Chinese medicine is in terms of medical material）Composition：
17~30 parts of bee pollen；
7~13 parts of Herba Taraxaci；
13~23 parts of Herba Portulacae；
8~15 parts of Herba Houttuyniae；
6~11 parts of Radix Platycodoniss；
11~19 parts of Poria；
5~9 parts of Semen Persicae；
4~8 parts of Radix Salviae Miltiorrhizae
2~6 parts of Radix Notoginseng
4~8 parts of black tea.
Further, the present invention treats the raw material of the prescription by following proportioning of benign prostatic hyperplasia（Chinese medicine is in terms of medical material） Composition：
Bee pollen：20~26 parts
Herba Taraxaci：9~12 parts
Herba Portulacae：15~20 parts
Herba Houttuyniae：10~13 parts
Radix Platycodoniss：8~11 parts
Poria：13~17 parts
Semen Persicae：6~9 parts
Radix Salviae Miltiorrhizae：4~6 parts
Radix Notoginseng：2~4 parts
Black tea：4~7 parts.
The preparation method of prescription of the present invention is：The water or 50-80% of 5~13 times of suitable raw material total amount are added in raw material Ethanol is extracted, 1~3 hour extraction time, is extracted 1~3 time；Extracting solution after extraction carry out after filtering it is concentrated in vacuo, It is 1.01~1.30 that 60-85 DEG C is concentrated into relative density, and concentrated solution is vacuum dried or is spray-dried, and obtains final product.
The prescription is preparing the purposes for treating benign prostatic hyperplasia.
The prescription is the form in solid preparation, such as medicinal tea, powder, granule.
The Main Ingredients and Appearance of medicine each component of the present invention includes：
Bee pollen：Aminoacid, saccharide and carbohydrate, lipid, vitaminss, mineral, enzyme, kinases, auxin, flavone Class etc..
Herba Taraxaci：Triterpeness, flavonoid, Coumarinses, Sesquiterpene lactones, phytosterol, pigment, volatile oil, Acetyl esters etc..
Herba Portulacae：Flavonoid, alkaloidss, polysaccharide, triterpene alcohols, organic acid, catecholamineses, trace element and Inorganic salts etc..
Herba Houttuyniae：Volatile oil, flavonoid, organic acid, sterols, alkaloid, vitamin, water soluble polysaccharide, metallic element And salt etc..
Radix Platycodoniss：Volatile oil, fatty acid, aminoacid, mineral, saponinss, phenols, flavonoid, carbene class etc..
Poria：Polysaccharide, triterpene, fatty acid, sterol, enzyme etc..
Semen Persicae：Lipid, glycoside, saccharide, protein, aminoacid, emulsin, allantoinase etc..
Black tea：Carotene, vitamin A, calcium, phosphorus, magnesium, potassium, caffeine, isoleucine, leucine, lysine, paddy ammonia The various nutrient elements such as acid, alanine, aspartic acid.
Radix Salviae Miltiorrhizae：Tanshinone Ⅰ, tanshinone IIA, tanshinone ⅡB, cryptotanshinone, Radix Salviae Miltiorrhizae methyl ester, miltirone, dihydro Radix Salviae Miltiorrhizae Ketone I, Methoytanshinone, quasi- TANSHINONES, Saprorthoquinone, Radix Salviae Miltiorrhizae glycol, Przewaquinone A Przewatanshinquinone A, own element etc..
Radix Notoginseng：Saponinss, dencichine, polysaccharide, flavonoid, alkynol class, volatile oil, trace element etc..
Inventor, through investigative test, finds out specific composition, specific for the etiology and pathogenesis of benign prostatic hyperplasia The combination of consumption, its clinical efficacy highly significant.Bee pollen function repercussive blood, diuresis in side, help spleen to help kidney, be full side Monarch；Herba Taraxaci, Herba Houttuyniae all can heat clearing and inflammation relieving, dehumidification swelling, tonneau bladder, Semen Persicae, Herba Portulacae all can blood circulation promoting and blood stasis dispelling, broken knot disappear Painful abdominal mass, promoting the circulation of QI dissipate strongly fragrant, and Radix Salviae Miltiorrhizae, Radix Notoginseng strengthen supplementing QI to induce diuresis, the work(of blood circulation promoting and dispersing pathogen accumulation, and the above instrumental ensembles heat clearing and inflammation relieving, promoting blood circulation to remove blood stasis Work(, be altogether the minister of full side；Again energy spleen invigorating makes antipyretic not imapirment of the spleen and stomach to Poria principal drug assistance eliminating dampness and promoting diuresis, is combined Radix Platycodoniss a surname and sends out a part of the body cavity above the diaphragm housing the heart and lungs Gas helps the unimpeded urethra of all medicines with " carry kettle and take off lid ", and both above are the assistant of full side；Using the gentle warming the stomach of black tea, coordinating the actions of various ingredients in a prescription is complete Side makes.
The present invention compared with prior art, has the advantage that：
（1）This clinical drug effect is obvious：To benign prostatic hyperplasia, can reach blood circulation promoting and blood stasis dispelling, heat clearing and inflammation relieving, dehumidification swelling, The effect of tonneau bladder.Easy to use, curative effect reliability, safety non-toxic can long-term taking；
（2）The prescription of the present invention is precise and appropriate, is made up of the Chinese medicine and black tea of conventional integration of edible and medicinal herbs, and medicine source understands, safety non-toxic, Wide material sources, it is cheap and easy to get；
（3）Preparation is simple, employs spray drying advanced technology, and taking convenience, dosage is accurately, economical and practical.
Specific embodiment
Embodiment one：Production medicinal tea
Composition（Unit of gram）：Bee pollen 23, Herba Taraxaci 11, Herba Portulacae 18, Herba Houttuyniae 12, Radix Platycodoniss 10, Poria 16, Semen Persicae 9, black tea 7th, Radix Salviae Miltiorrhizae 6, Radix Notoginseng 4
First by above-mentioned ten kinds of raw materials, weigh by recipe quantity and assort, in being put into extraction pot, plus the water extraction of 7 times of amounts, extraction 2 times, often Secondary 2 hours, filter after united extraction liquid, it is 1.1 that 70 DEG C are concentrated into relative density, is spray-dried, and subpackage is obtained final product.
Embodiment two：Production powder
Composition（Unit of gram）：Bee pollen 21, Herba Taraxaci 10, Herba Portulacae 17, Herba Houttuyniae 12, Radix Platycodoniss 11, Poria 16, Semen Persicae 9, black tea 6th, Radix Salviae Miltiorrhizae 6, Radix Notoginseng 5
First by above-mentioned ten kinds of raw materials, weigh by recipe quantity and assort, in being put into extraction pot, plus 10 times of 70% ethanol of amount are extracted, and extract 3 It is secondary, 2 hours every time, filter after united extraction liquid, it is 1.2 that less than 80 DEG C are concentrated into relative density, and vacuum drying is crushed, mistake Sieve, subpackage is obtained final product.
Embodiment three：Production granule
Composition（Unit of gram）：Bee pollen 21, Herba Taraxaci 10, Herba Portulacae 17, Herba Houttuyniae 12, Radix Platycodoniss 9, Poria 16, Semen Persicae 8, black tea 6th, Radix Salviae Miltiorrhizae 7, Radix Notoginseng 4
First by above-mentioned ten kinds of raw materials, weigh by recipe quantity and assort, in being put into extraction pot, plus 12 times of 60% ethanol of amount are extracted, and extract 1 It is secondary, extract 3 hours, filter after extracting solution, it is 1.30 that less than 60 DEG C are concentrated into relative density, and vacuum drying is crushed, and is sieved, and is mixed Even, granulation, subpackage is obtained final product.
Experiment and evaluation of clinical curative effect
（One）Impact of the invention to hormone induction mouse prostate hypertrophy
Mouse experiment prostatic hyperplasia model is induced using subcutaneous injection testosterone propionate, while continuous 3 weeks gavages give 125th, after sample prepared by the embodiment of the present invention 1 of 250 and 500mg/kg tri- kinds of various doses, mouse prostate is determined respectively Weight in wet base, calculating prostate index, serum testosterone（T）Malonaldehyde in content, prostata tissue（MDA）Content, oxidation resistance refer to Number（ORAC）, glutathion（GSH）Level.It is prepared by prostatic hyperplasia model：By experiment mice be randomly divided into Normal group, BPH model group, 0.65mg/kg Proscar groups, 125mg/kg, 250mg/kg and 500mg/kg embodiment of the present invention 1 prepare sample Group, totally 6 groups, 10 per group.Except Normal group is injected with capacity olive oil solution, the equal subcutaneous injection 5mg/ of remaining each group animal Kg Testosterone Propionate olive oil lysates, gastric infusion after daily subcutaneous injection 30min, Normal group and model group are given with appearance Amount aqueous solution.Fasting 24h after last dose, etherization is put to death after weighing.
Testing index：
The measure of prostate index (PI)：After sacrifice, dorsal part leaf prostate is carefully separated, use electronics after being stripped clean immediately Balance is weighed, and calculates prostate wet weight, prostate index.（Prostate index=prostate wet weight/body weight, unit：mg·g-1）
Testosterone in serum（T）Determine：Whole blood is stood after 1h, and 3000r/min centrifugations 15min separates serum under the conditions of 4 DEG C, determines Testosterone Content in Serum.Testosterone concentration adopts I in serum125The serum testosterone ria-determination test kit of labelling, with liquid equilibrium competition Radio immunoassay（RIA）Determine.I125Labelled antigen（*Ag）With unlabelled antigen（Ag）Competition limitation antibody（Ab）On Binding site, according to Ag concentration and * Ag-Ab complex in negatively correlated functional relationship, is carried out quantitatively to sample.
The malonaldehyde of prostata tissue（MDA）Determine：It is even that prostata tissue homogenised sample makes 5% tissue with normal saline Slurry, under the conditions of 4 DEG C with the centrifugation 10min of 10000r/min after, take supernatant and determine wherein MDA contents.Prostate group Knit middle MDA contents to determine using MDA detection kit.Measuring principle is can be with thiobarbituricacidα- using MDA（TBA）Condensation, Red product is formed, there is the property of maximum absorption band at 532nm, be measured by colorimetry.Egg in prostata tissue Bai Hanliang is detected with Coomassie brilliant blue protein determination kit.
The nitric oxide of prostata tissue（NO）Determine：NO in prostata tissue is determined and is adopted Griess chemical methods, The preparation of Griess reagents equal-volume in using front 12h by 0.1% naphthodiamide solution and 1% sulfanilamide (5%) phosphoric acid solution Mixing for standby use.The normal saline homogenate μ L of supernatant 40 for taking 2% Prostate tissue specimens are added in 160 μ LGriess reagents, are mixed It is even, after standing 20min, its UV absorption, the level (μ of the NO in NO standard curves computation organization are determined at 550nm mol/mL)。
The ORAC of prostata tissue（ORAC）Determine：ORAC is determined in ORAC methods, its Principle be fluorescein sodium in the case where 485nm light is excited, 527nm fluorescence can be launched.AAPH is in aqueous by discharging peroxide freedom Base, fluorescein sodium is aoxidized so as to which fluorescent characteristic disappears.In the presence of antioxidant, can subtract with fluorescein sodium competitive oxidation agent Delay the speed that its fluorescence disappears.According to this response characteristic, can determination sample to oxygen radical removing activity.Actual result is expressed For fluorescence decay curve lower integral area, the blank area under curve without antioxidant is deducted, draw the protection face of antioxidant Product, and carry out Quantitative Comparison with the protected area of 1 molL-1 Trolox.Concrete assay method is prepared into 3% perchloric acid 2% prostata tissue Deproteinization is homogenized, and with the centrifugation 15min of 10000r/min under the conditions of 4 DEG C, takes supernatant as survey Determine the sample of ORAC.Determination step is that 20 μ L prostata tissue homogenates of variable concentrations are added in 96 orifice plates, then is added successively Enter 140 μ L AAPH and the above-mentioned phosphate buffers of 20 μ L, finally to add and rapidly 96 orifice plates are placed in into setting after 20 μ L fluorescein sodium Start to determine in the fluorescence microplate reader that 37 DEG C of temperature.A point is determined per 2min, 2h is determined altogether.The ORAC values of prostata tissue are Using the Trolox of 1 μm of ol/L, corresponding protection integral area is calculated as standard control on fluorescence decay curve.
The glutathion of prostata tissue（GSH）Determine：Mouse prostate tissue 3%PCA homogenate under the conditions of 4 DEG C with The centrifugation of 12000 r/min 15 minutes, takes out supernatant and is preserved for GSH with -20 DEG C after 0.45 μm of filtering with microporous membrane Analysis.GSH is determined and is used Japan Nacalai Tesque company Cosmosil series 5C18Post（4.6mm×150mm）, mobile phase For 99mmol/L phosphate buffers（pH2.5）, 1% methanol, 200mg/LSOS, 5mg/L EDTA.25 DEG C of column temperature, flow rate set 1mL/min, voltage 600mV, sampling volume is 20 μ L.Standard control GSH is dissolved and -20 DEG C after diluting with 0.05 mol/L HCL Preserve.The preparation process of reference substance storing solution needs to be operated under cryogenic.The μ L of sample feeding 20 for preparing are determined Its peak area, with peak area y (mvs) according to regression equation：Y=169223x+344923 calculates concentration x (the μ gmL- of sample 1)。
Statistical procedures：Experimental data carries out statistical procedures, p to represent with Student ' s t-test inspections<0.05 It is statistically significant.
Impact to mice benign prostatic hyperplasia：Shown in table 1, with Testosterone Propionate mouse prostate model of hyperplasia group is induced Than the embodiment of the present invention 1 of 500mg/kg prepares sample sets can substantially reduce mouse prostate weight in wet base (P<And prostate 0.01) Index (P< 0.05).When level of serum testosterone change is inquired into, it is found that the 500mg/kg embodiment of the present invention 1 prepares sample sets energy It is obviously improved the rising (P of mice serum testosterone levels< 0.01).
The embodiment of the present invention 1 prepares improvement result result of the sample sets to mice oxidative stress status：Shown in table 2, visiting Beg for when the embodiment of the present invention 1 prepares impact of the sample sets to prostatic hyperplasia mouse prostate tissue oxidizing stress state and confirm, Compared with model group, the embodiment of the present invention 1 prepares sample sets and can effectively raise prostata tissue GSH contents, reduces mice prostatitis Glandular tissue MDA levels, alleviate the decline of mouse prostate tissue ORAC (ORAC) level and NO levels, and have A certain amount imitates relation (P<0.05 or P< 0.01).
（One）Impact of the invention to implantation induced mice prostatic hyperplasia
Mice 50, male, 27~30g of body weight is randomly divided into low tested material, high dose, positive drug control, model and blank Totally 5 groups, 10 per group of control.In addition to blank control group only makees sham-operation, remaining each group mice carries out respectively implant surgery.Mice After ip pentobarbital sodiums 60mg/kg anesthesia, sterile working cuts hypogastric region open, carefully separates prostate siphonal lobe, under anatomical lens, uses The sharp clock and watch tweezers in tip are implanted into the urogenital sinuss tissue of 3 16d age tire Mus to prostate siphonal lobe, and blank control group is carried out Same operation technique, but only with forceps tips thorn human prostate tissue twice, as heel in into.Confirm on inspection after implantation, by Layer suturing them, packet administration after 3d.Tested material treatment group mice respectively the ig embodiment of the present invention 2 prepare sample 250mg/kg and 500mg/kg (Qd × 30d), positive controls mice sc estradiol benzoate 0.5mg/kg (Q 3d × 30d), model and blank Control group mice then distinguishes ig distilled water (Qd × 30d).24h after last dose, carefully take prostate siphonal lobe, notopodium, lateral lobe, And seminal vesicle and testis, claim its weight in wet base.Meanwhile, take prostata tissue and survey its DNA content.It is public according to each leaf Index for Calculation of prostate Formula, by each leaf weight conversion exponentially of prostate.The each leaf formula of index of prostate:Each leaf index (the %)=prostate of prostate Each leaf weight (g) ÷ body weight (g) × 100%
The impact of induced mice prostatic hyperplasia is implanted into urogenital sinuss, to the mice ig embodiment of the present invention 2 sample sets are prepared （250mg/kg and 500mg/kg）, urogenital sinuss are implanted into caused prostatic hyperplasia model mouse prostate siphonal lobe weight saving, front Row glandular tissue DNA content significance declines（P<0.05）, but seminal vesicle, testicular weight are had no significant effect.It is shown in Table 3.
（Three）Evaluation of clinical curative effect
The contrast for suffering from the random group experiment of benign prostatic hyperplasia hypertrophy patient by 90：Treatment group adopts the embodiment of the present invention 3 The sample of middle preparation, matched group oral hydrochloride terazosin piece.
90 patient ages 45-80 year（Including 45,80 one full year of life）Male；Qmax ＜ 15ml/s；The course of disease 3 months with On.According to IPSS score-systems, wherein 8-19 point 67,20-35 point, 23, diagnosis meets Chinese Medical Association in 2005 and secretes Urine Society of Surgery promulgates《Benign prostatic hyperplasia diagnoses and treatment guide》, and exclude to this product allergy sufferers or allergic constitution；Close And intentionally, cerebrovascular, severe primary disease and the psychotic such as liver, kidney and hemopoietic system；Serious neurological systemic disease, vertebra The neurogenic bladder that the narrow, prolapse of lumbar intervertebral disc of pipe, pelvic cavity or hypogastric region major operation, severe diabetes mellitus cause；Neck of bladder Fibrosiss, interureteric ridge are loose, seminal colliculus is loose, the dysuria that urethral stricture causes；Merge urinary tract infection, lithangiuria, Prostatitis, patients with prostate cancer；Benign prostate obstruction invasive Endodontic failure person；Taking may affect bladder outlet The medicine of function；Non-drug therapy indication person.All cases have different degrees of frequent micturition, urgent micturition, urine retention, urination tired Difficulty, or even have the symptoms such as urine retention or urinary incontinence.
Therapeutic Method：
Matched group oral hydrochloride terazosin piece（Hytrin, Shanghai Abbott GmbH. ＆ Co. Kg）1 tablet once, once a day.
The oral embodiment of the present invention 3 for the treatment of group prepares sample, 2 bags every time, daily 2 times.
The equal course for the treatment of of January one of above two Therapeutic Method, two courses for the treatment of of continuous drug administration.
Criterion of therapeutical effect：1) clinical recovery or effective：Clinical symptom disappearance or basic disappearance IPSS score<7, or color ultrasound examination Prostate is close to normal or contracting and reduces more than 30% earlier above；2) effectively：Clinical symptoms are obviously improved, and IPSS scorings reduce more than 50% Or the contracting of color ultrasound examination prostate reduces earlier above more than 15%；3) it is invalid：Clinical symptoms improve not substantially, or color ultrasound examination prostatitis Gland contracting is reduced do not reach 15% earlier above.
Two groups of Clinical efficacy comparisons
3 sample treatment group of the embodiment of the present invention 45, clinical cure or effective 32, effective 10, invalid 3, total effective rate 93.33%.And without obvious adverse reaction.Matched group 45, respectively 10,27,8,82.22%, untoward reaction sexual impotence, property It is intended to go down 3.Pain is uncomfortable 1.Two groups of comparitive study treatments are with the obvious advantage（p<0.05）.
Untoward reaction：Treatment group does not find obvious adverse reaction；There is untoward reaction sexual impotence or hyposexuality 3 in matched group Example, pain is uncomfortable 1.
Conclusion：The sample sets of the embodiment of the present invention 3 are still made before hypertrophy no matter in terms of patient clinical symptom is mitigated Row gland atrophy aspect is significantly better than that matched group, and without obvious adverse reaction.
It is of the invention to be safely and effectively difficult bounce-back, can long-term taking.

Claims (6)

1. a kind of prescription, it includes bee pollen, Herba Taraxaci, Herba Portulacae, Herba Houttuyniae, Radix Platycodoniss, Poria, Semen Persicae, black tea, Radix Salviae Miltiorrhizae and three Seven.
2. prescription according to claim 1, it is characterised in that by the raw material of following proportioning（Chinese medicine is in terms of medical material）Composition：
17~30 parts of bee pollen；
7~13 parts of Herba Taraxaci；
13~23 parts of Herba Portulacae；
8~15 parts of Herba Houttuyniae；
6~11 parts of Radix Platycodoniss；
11~19 parts of Poria；
5~9 parts of Semen Persicae；
4~8 parts of Radix Salviae Miltiorrhizae
2~6 parts of Radix Notoginseng
4~8 parts of black tea.
3. according to the prescription of any one of claim 1 to 2, it is characterised in that by the raw material of following proportioning（Chinese medicine is in terms of medical material）Group Into：
Bee pollen：20~26 parts
Herba Taraxaci：9~12 parts
Herba Portulacae：15~20 parts
Herba Houttuyniae：10~13 parts
Radix Platycodoniss：8~11 parts
Poria：13~17 parts
Semen Persicae：6~9 parts
Black tea：4~7 parts
Radix Salviae Miltiorrhizae：4~6 parts
Radix Notoginseng：2~4 parts.
4. the method for preparing the prescription of any one of claims 1 to 3, it is comprised the following steps：
The water or 50-80% ethanol that 5~13 times of suitable raw material total amount is added in raw material is extracted, and 1~3 hour extraction time, is carried Take 1~3 time；Extracting solution after extraction carry out after filtering it is concentrated in vacuo, less than 60-85 DEG C be concentrated into relative density for 1.01~ 1.30, concentrated solution is vacuum dried or is spray-dried, and obtains final product.
5. prescription described in any one of Claims 1-4 item is preparing the purposes for treating benign prostatic hyperplasia.
6. according to the purposes of claim 5, wherein the prescription is the form in solid preparation, such as medicinal tea, powder, granule Deng.
CN201610973118.1A 2016-11-07 2016-11-07 Botanical formula for treatment of benign prostatic hyperplasia and preparation method thereof Pending CN106668329A (en)

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* Cited by examiner, † Cited by third party
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CN109757582A (en) * 2018-12-29 2019-05-17 江苏鹤莱科技有限公司 Improve the nutritional food formula of benign prostate hyperplasia shape
CN117018121A (en) * 2018-04-02 2023-11-10 王庆友 Traditional Chinese medicine formula for treating prostatic hyperplasia

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117018121A (en) * 2018-04-02 2023-11-10 王庆友 Traditional Chinese medicine formula for treating prostatic hyperplasia
CN109757582A (en) * 2018-12-29 2019-05-17 江苏鹤莱科技有限公司 Improve the nutritional food formula of benign prostate hyperplasia shape

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Application publication date: 20170517