CN105641217A - Pharmaceutical composition for treating prostatic hyperplasia - Google Patents

Pharmaceutical composition for treating prostatic hyperplasia Download PDF

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CN105641217A
CN105641217A CN201610047112.1A CN201610047112A CN105641217A CN 105641217 A CN105641217 A CN 105641217A CN 201610047112 A CN201610047112 A CN 201610047112A CN 105641217 A CN105641217 A CN 105641217A
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weight portion
pharmaceutical composition
ethanol
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prostatic hyperplasia
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不公告发明人
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Jinan Xingyi Medical Technology Co Ltd
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Abstract

The invention discloses a pharmaceutical composition for treating prostatic hyperplasia and a preparation method thereof. The pharmaceutical composition is prepared by taking rallus apuaticus(Linnaeus), twigs and leaves of eurya japonica, hydroxyevodiamine, twigs and leaves of eurya japonica, herb of thyrocarpus sampsonii Hance. and roots or herb of radix pleurospermi tibetanici as bulk pharmaceuticals in proportion and can be prepared into various dosage forms according to a conventional preparation technology, and the prostatic hyperplasia treatment effect is significant.

Description

A kind of pharmaceutical composition treating prostatic hyperplasia
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition treating prostatic hyperplasia and preparation method thereof.
Background technology
Hyperplasia of prostate is the commonly encountered diseases of elderly men, frequently-occurring disease, belongs to the traditional Chinese medical science " difficulty in urination " category. The traditional Chinese medical science is thought, the difficulty in urination is to cause hypourocrinia due to kidney and bladder qi dysfunction, dysuria, and very then urine obturation is obstructed is the disease led. The unobstructed gasification not only depending on kidney and bladder of urine, and from the whole relation between internal organs, the absorption of water liquid, operation, excretion, also depends on the logical tune of the gasification of three Jiao and lung spleen kidney, transfers, evaporates. Make a general survey of the sick position of primary disease, main at bladder, but in three burnt, lung spleen Liver and kidney is closely related. Chinese medicine primary disease has curative effect certainly. The main manifestations of primary disease is dysuria, therefore should be conceived to lead to. Its sick position is at bladder, but and kidney, liver, lung, spleen, three burnt in close relations. Its pathogenesis has that kidney yang is feeble and exhausted, deficiency of kidney-YIN, damp-heat accumulation, lung-heat with QI-obstruction, stagnation of QI due to depression of the liver, spleen-QI failing to rise up, urethral obstruction number end. Treatment first has to catch primary symptom, determination of cause of disease according to differentiation of symptoms and signs; It is secondary distinguishes deficiency and excess according to syndrome; Then weigh the relative importance again emergency, treat. Deficiency syndrome control should spleen reinforcing kidney, help gasification to make to gasify capable, urine is from logical; Excess syndrome is controlled should clearing away damp-heat, dissipating blood stasis knot, lung qi dispersing gas, soothing the liver strongly fragrant and waterway. Therefore Chinese medicine compound determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, deficiency syndrome should be treated by tonifying method, sthenia syndrome requiring purgation, it is possible to better take into account all cards, play its effect altogether. The composite treatments such as external application can be adopted at oral medicine simultaneously simultaneously, in order to avoid its change raw. But treatment primary disease still suffers from weak point, in clinical observation, the diagnostic criteria that adopts, criterion of therapeutical effect, case selection standard still disunity, differentiation of symptoms and signs for classification of syndrome is different, is unfavorable for screening effective prescription and medicine. Many deficiencies, all need to be further improved and supplement. This disease is born in middle-aged and elderly people clinical multiple, in chronic progression, it is contemplated that its developmental stage, thinking along with the development of the course of disease, pathogenic characteristic is likely to be stage distribution, and the initial stage is in the majority with excess syndrome, mid-term simulataneous insufficiency and excessive, the later stage is how in the majority with deficiency syndrome, therefore it is contemplated that interim research and treat this disease. Along with the intensification to the cause of disease, pathogenesis understanding, the application for the treatment of and prevention, in conjunction with modern medical techniques and Chinese medicine all-round cooperation research, the especially research of side's medicine and pathogenesis, all need further deeply.
Radix Thyrocarpi sampsonii: the herb of Boraginaceae Radix Thyrocarpi sampsonii platymiscium Radix Thyrocarpi sampsonii ThyrocarpussampsoniiHance. 4��June adopts herb, dries. [nature and flavor] are bitter; Cool. [return through] heart; Large intestine channel. [function cures mainly] clearing heat, releasing toxin, removing swelling. Main carbuncle; Furuncle; Have sore throat; Have loose bowels; Dysentery. [character] stem is relatively thin, and 1 to several, cylindrical, long 10-30cm, the withered green in surface, has the rough hair of canescence, the crisp frangibility of matter, section white. ?he ? ? preesed rock ? ? ? Jia of ? ? Hou that falls from the sky or outer space in hole binds round the ? Xi ? son ? that endangers and murders ? ? ? .5-19cm, wide 1-5cm, withered green or bottle green, and two sides all has canescence coarse wool, and stem leaf is less, stockless. Blade is slightly thick. Sometimes visible indigo plant or purple little Hua. Or having the pyrene of the bowl-shape projection of two-layer, base top exterior layer has upright gear, and internal layer is close to edge. Feeble QI mildly bitter flavor. Record in Chinese medicine voluminous dictionary.
Carnis Rallus aquaticus: this product is the meat that Rallidae Carnis Rallus aquaticus belongs to animal Carnis Rallus aquaticus Rallusapuaticus (Linnaeus). The four seasons all can catch, and after catching, removes feather and internal organs, takes meat. [nature and flavor] sweet in the mouth; Warm in nature. [return through] large intestine channel. [function cures mainly] removing toxic substances parasite killing; Invigorating the spleen and replenishing QI. Main ant fistula; Weakness of the spleen and stomach; Inappetence. [former zoomorphism] Carnis Rallus aquaticus, body is about 30cm. Little; Neck length. Upper body feather taupe, band black speckle, head speckle is particularly significant. Two wing surfaces are most grey brown. Lower body brown, two axil tool white maculas; Crissum is identical with lower tall coverts black and white, plumage end white. Shin plumage is black and has white horizontal speckle. Mouth is dark brown, and lower mouth base portion is thin. Foot sepia. Record in Chinese medicine voluminous dictionary.
Ramulus et Folium Euryae Japonicae: for branch and leaf or the fruit of plant of theaceae Ramulus et Folium Euryae Japonicae EuryajaponicaThunb.. [nature and flavor] are bitter; Puckery; Cool. [return through] spleen; Bladder warp. [function cures mainly] expelling wind and clearing away heat; Inducing diuresis to remove edema; Hemostasia and promoting granulation. Main air pain of dampness syndrome; Ascites expands; Heating xerostomia; Skin ulcer swells; Treating swelling and pain by traumatic injury; Wound hemorrhage. [character] branch Lycoperdon polymorphum Vitt, hole skin is obvious, has a trace and stipe scar. Leaf crushes more, intact leaf lanceolar, long 4-6cm, wide 1.5-2cm, and tip is anxious sharp or tapering, base portion wedge shape, and there are thin crenature or indentation in edge; Surface yellow green or dirty-green, tender leaf color is light, has a pubescence, and Lao Ye color depth is more smooth; Keratin. Fruit is irregular spherical, shrinkage, diameter 3-4mm, kermesinus or atropurpureus. Feeble QI, mildly bitter flavor. Containing Catergen 9-219mg/100g in the leaf that [chemical analysis] is fresh. Fruit is containing Chrysanthemin (chrysanthemin), cyanidin 3-acetyl rutinoside (cyanidin3-acetylrutinodide); Flower flower glycoside containing Ramulus et Folium Euryae Japonicae (euryanoside), the auspicious ketone of Harry (halleridone) and wood carry out wooden glycoside (cornoside). [former phytomorph] Ramulus et Folium Euryae Japonicae shrub, high 1-3m. Twig has rib, without hair or there is thin hair. Single leaf alternate; The long 2-5mm of petiole; Blade keratin, becomes two column-shaped, oval to round shape lanceolar, long 3-6cm, wide 1.5-3cm, tip sharp point or tapering, nick, base portion wedge shape, edge tool cognate, above bottle green, below yellow green, two sides is all without hair, and master pulse sink herein above, and lateral vein is inconspicuous. Flower unisexuality, dioecism, normal 1-3 clusters in axil and branch side; Bennet is short, sagging; Sepal 5, subcircular, harbor; Petal 5, white or yellow green, avette, base portion Colaesce; The stamen of male flower is most, is shorter than petal, degeneration ovary with or without; Female flower is without stamen, and style is short, and tip 3 is shallow to be split. Berry spheroidal, footpath is about 5mm, atropurpureus time ripe. The month at florescence 3-4, fruit month phase 7-8. Record in Chinese medicine voluminous dictionary.
Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke: for samphire Herba pleurospermi thomsonii PleurospermumhookeriC.B.Clardevar.thomsoniiC.B.Clarke [P.dochenenseW.W.Smith; P.tibetanicumWolff.] root or herb. Summer, autumn gather, and clean earth, dry. ?rrest dizzy fourth class surplus grain all of a sudden suddenly and swoon grand all of a sudden! Unexpectedly an anti-sweet oak III rolling good fortune spring Chinese alligator ? of tenon ?! Unexpectedly the towering clod of earth whetstone ? �� good fortune of �� kohlrabi bangs change the titanium grand V of ? ? offer to ? ? melt mark Huan employ spring culter of standing tall and upright to wish the lie ? brightness that stand tall and upright is killed ? bad sole and is changed and flutter ?! Office's ginseng engraves the fervent Sha of ? father-in-law ? bright ? bitter edible plant Jing ? ? 0-40cm. Herb is without hair. Root is carefully cylindrical, crineous, footpath 4-6mm. Stem is upright, single or grow thickly, cylindrical, has striped. Stem leaf is most, even the long 10-20cm of petiole; Blade profile triangle, two to three times pinnation, accessory pinna 7-9 pair, an accessory pinna lanceolar or ovum shape lanceolar, sliver width wedge shape is returned at end, and length and width are about 5mm respectively, and accessory pinna drastic crack is linear lobelet; Stem upper leaf and basal leaf similar shape, petiole is sheath shape. Universal umbel top is raw or side is raw; Phyllary 5-7, wire lanceolar, top shape of tail divides, the filbert transparent film quality in edge; Umbrella spoke 6-12; Involucel sheet 7-9, with phyllary similar shape; Umbellule spends majority, the narrow triangle of calyx tooth; Petal white, subcircular; Flower pesticide mulberry; Style is short, fork. Diachenium oval, long 3-4mm, fruit rib has narrow wing, has oil pipe 3, symphysis face oil pipe 6 in every rib groove. August at florescence, fruit month phase 9-10. Record in Chinese medicine voluminous dictionary.
Hydroxyevodiamine (Hydroxyevodiamine): CAS 1238-43-3, molecular formula C19H17N3O2, molecular weight 319.36. [ingredient origin] Fructus Evodiae Evodiarutaecarpa..
1 crude drug chemical constitution:
Hydroxyevodiamine (Hydroxyevodiamine).
Summary of the invention
It is an object of the invention to overcome the deficiency of background technology, it is provided that pharmaceutical composition of a kind of effective treatment prostatic hyperplasia and preparation method thereof.
The present invention adopts the following technical scheme that realization:
Composition and the weight portion of making the crude drug of the pharmaceutical composition of this treatment prostatic hyperplasia be:
Carnis Rallus aquaticus 6080-6090 weight portion Ramulus et Folium Euryae Japonicae 3060-3070 weight portion Hydroxyevodiamine 220-250 weight portion Radix Thyrocarpi sampsonii 1408-1410 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 900-920 weight portion.
It is preferably used in the pharmaceutical composition for the treatment of prostatic hyperplasia, is prepared by the crude drug composition of weight portion:
Carnis Rallus aquaticus 6085 weight portion Ramulus et Folium Euryae Japonicae 3065 weight portion Hydroxyevodiamine 235 weight portion Radix Thyrocarpi sampsonii 1409 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 910 weight portion.
A kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare into tablet or capsule or drop pill.
A kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that the treatment prostatic hyperplasia agents that pharmaceutical composition forms with chemical drugs or Chinese medicine.
The preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: Carnis Rallus aquaticus 6080-6090 weight portion Ramulus et Folium Euryae Japonicae 3060-3070 weight portion Hydroxyevodiamine 220-250 weight portion Radix Thyrocarpi sampsonii 1408-1410 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 900-920 weight portion;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preferably preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: Carnis Rallus aquaticus 6085 weight portion Ramulus et Folium Euryae Japonicae 3065 weight portion Hydroxyevodiamine 235 weight portion Radix Thyrocarpi sampsonii 1409 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 910 weight portion;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare into tablet or capsule or drop pill.
The preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment prostatic hyperplasia agents.
Medicine composite for curing prostatic hyperplasia is evident in efficacy.
Detailed description of the invention
Embodiment 1: pharmaceutical composition for the treatment of prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of prostatic hyperplasia be: Carnis Rallus aquaticus 6085g Ramulus et Folium Euryae Japonicae 3065g Hydroxyevodiamine 235g Radix Thyrocarpi sampsonii 1409g Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 910g;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 2: pharmaceutical composition for the treatment of prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of prostatic hyperplasia be: Carnis Rallus aquaticus 6080g Ramulus et Folium Euryae Japonicae 3070g Hydroxyevodiamine 220g Radix Thyrocarpi sampsonii 1410g Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 900g;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 3: pharmaceutical composition for the treatment of prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition for the treatment of prostatic hyperplasia be: Carnis Rallus aquaticus 6090g Ramulus et Folium Euryae Japonicae 3060g Hydroxyevodiamine 250g Radix Thyrocarpi sampsonii 1408g Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 920g;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 4: the preparation of tablet
Example 1 pharmaceutical composition 236g, adds starch 273g, mixing, granulates, dry, adds microcrystalline Cellulose 26g, magnesium stearate 2.1g, and mixing is pressed into 1500, obtains medicinal composition tablets.
Embodiment 5: the preparation of capsule
Example 2 pharmaceutical composition 251g, adds starch 249g, mixing, granulates, dry, and granulate adds appropriate magnesium stearate, mixing, encapsulated 1500, obtains medicament composition capsule.
Embodiment 6: the preparation of drop pill
Weigh polyethylene glycol 6000 256g water-bath (80 DEG C) heating and boil molten, add embodiment 3 pharmaceutical composition 13.4g, stir, with liquid paraffin for coolant, put in glass tubing (4*80cm), chilling temperature is 5 DEG C, drip internal-and external diameter is 7.0/2.0 (mm/mm), and drip is 2.6cm from liquid level, drips speed with per minute 63 for optimum condition, blot the condensing agent on drop pill surface with cotton, obtain medicament composition dropping pills.
Experimental example 1: the experimental study for the treatment of prostatic hyperplasia
1 clinical data
1.1 physical data
30 example patients are Urology Surgery and the clinic case of combination of Chinese and Western medicine prostate section, in January ,-2012 observing time from April, 2011. Adopt random digits table to be divided into 2 groups, treatment group 15 example, wherein 50-59 year 3 examples, 60-69 year 5 examples, 70-79 year 4 examples, more than 80 years old 3 examples, on average (62.6 �� 10.1) year; The course of disease 9 months-16.5 years, average 6.26 years. Matched group 15 example, wherein 50-59 year 3 examples, 60-69 year 5 examples, 70-79 year 4 examples, more than 80 years old 3 examples, average (62.6 �� 10.1) year; The course of disease 9 months-16.5 years, average 6.26 years. Two groups of no significant difference in age, the course of disease (P > 0.05), have comparability.
1.2 diagnostic criterias
" the new Chinese medicine guideline of clinical investigations " issued with reference to Ministry of Health of the People's Republic of China in 1997 is drafted: (1) starts to behave as frequent micturition, nocturia increased frequency, gradually has dysuria, and urine line is carefully unable, can have urine retention or urinary incontinence time serious; (2) Rectal tonch: prostate two lateral lobe expands, and Rolandic fissure shoals or disappears; (3) super inspection: prostate size measurement compared with normal increases, residual urine volume > 10ml. Chinese medical discrimination meets damp and hot double blood stasis syndrome etc. of suffering from a deficiency of the kidney.
1.3 inclusive criterias
(1) age more than 50 years old; (2) prostate volume is more than normally. Through patient's informed consent.
1.4 exclusion standards
(1) carcinoma of prostate; (2) tuberculosis of prostate; (3) acute and chronic prostatitis; (4) vesical calculus; (5) tumor of bladder; (6) glandular cystitis; (7) urethral stricture; (9) calculus of prostate.
2 Therapeutic Method
2.1 treatment groups
Drug administration compositions (embodiment 1 pharmaceutical composition lot number 20100716). Each 1.0g, every day 3 times. It within 3 months, it is 1 course for the treatment of. Avoid during taking medicine and drink, avoid pungent food.
2.2 matched groups
Take Tamsulosin capsule (Harnal), take every night 1 time, each 0.2mg. The course for the treatment of and points for attention are with treatment group. All treat statistics curative effect after 1 course for the treatment of for two groups.
3 observation of curative effect
3.1 criterions of therapeutical effect
" the new Chinese medicine guideline of clinical investigations " issued with reference to Ministry of Health of the People's Republic of China in 1997 is drafted. Effective: international contest (IPSS scoring) 7 points, or state of an illness total mark reduction >=90%, prostate volume is reduced into original less than 60%, and residual urine volume reduces more than 80%, more than possesses 2.Effective: IPSS mark 13 points but>7 points, or state of an illness total mark reduces>60% but<90%, prostate volume is reduced into original less than 80%, and residual urine volume reduces more than 50%, more than possesses 1. Invalid: not reach effective standard.
3.2 liang of group Clinical efficacy comparisons
Treatment group 15 example, effective 6 examples, effective 8 examples, invalid 1 example, total effective rate is 93.33%; Matched group 15 example, effective 4 examples, effective 7 examples, invalid 4 examples, total effective rate is 73.33%. Two groups of Clinical efficacy comparisons, treatment group is substantially better than matched group (P < 0.05).
Before and after 3.3 liang of group treatments, cardinal symptom and objective indicator compare
Table 1 shows, after two groups of treatments, indices compares with before treatment, difference all statistically significant (P < 0.05 or P < 0.01); Comparing with after treatment of control group, treatment group indices is substantially better than matched group (P < 0.05 or P < 0.01).
Before and after 1 liang of table group patient treatment, prostate volume, IPSS scoring, life quality scores, residual urine volume compare (x �� s)
Note: with this group before treatment, * P < 0.05, * * P < 0.01; Compare with after treatment of control group, #P < 0.05, ##P < 0.01.

Claims (8)

1. the pharmaceutical composition treating prostatic hyperplasia, it is characterised in that composition and the weight portion of making the crude drug of this pharmaceutical composition be:
Carnis Rallus aquaticus 6080-6090 weight portion Ramulus et Folium Euryae Japonicae 3060-3070 weight portion Hydroxyevodiamine 220-250 weight portion Radix Thyrocarpi sampsonii 1408-1410 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 900-920 weight portion.
2. a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 1, it is characterised in that composition and the weight portion of making the crude drug of this pharmaceutical composition be:
Carnis Rallus aquaticus 6085 weight portion Ramulus et Folium Euryae Japonicae 3065 weight portion Hydroxyevodiamine 235 weight portion Radix Thyrocarpi sampsonii 1409 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 910 weight portion.
3. a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 1, it is characterised in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare into tablet or capsule or drop pill.
4. a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 1, it is characterised in that the treatment prostatic hyperplasia agents of pharmaceutical composition and chemical drugs or Chinese medicine composition.
5. the preparation method of the pharmaceutical composition treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: Carnis Rallus aquaticus 6080-6090 weight portion Ramulus et Folium Euryae Japonicae 3060-3070 weight portion Hydroxyevodiamine 220-250 weight portion Radix Thyrocarpi sampsonii 1408-1410 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 900-920 weight portion;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
6. the preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 5, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: Carnis Rallus aquaticus 6085 weight portion Ramulus et Folium Euryae Japonicae 3065 weight portion Hydroxyevodiamine 235 weight portion Radix Thyrocarpi sampsonii 1409 weight portion Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke 910 weight portion;
Preparation method:
(1) by crude drug proportioning seedling taking chicken, Ramulus et Folium Euryae Japonicae, Hydroxyevodiamine, Radix Thyrocarpi sampsonii, Pleurospermum hookeri C.B.Clarde var.thomsonii C.B.Clarke, mixing, with weight percent concentration 15% ethanol as solvent, extract at 27 DEG C of warm macerating, extraction time is 12 times, each extraction time is 1.4 hours, each solvent load is 23 times of crude drug gross weight, filter, obtain medicinal residues A and extracting solution A, extracting solution A reclaims ethanol, it is concentrated into relative density 1.06, filter, medicinal liquid passes through SD101 macroporous adsorptive resins, first wash with water, again with weight percent concentration 61.5% alcoholic solution eluting SD101 macroporous adsorptive resins, collect weight percent concentration 61.5% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 56% ethanol as solvent, heating and refluxing extraction 13 times, each extraction time is 0.3 hour, each solvent load is 24 times of medicinal residues A weight, filter, obtain medicinal residues B and extracting solution B, extracting solution B reclaims ethanol, it is concentrated into relative density 1.13, filter, medicinal liquid passes through DM131 macroporous adsorptive resins, first wash with water, again with weight percent concentration 77% alcoholic solution eluting DM131 macroporous adsorptive resins, collect weight percent concentration 77% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
7. the preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 5, it is characterised in that pharmaceutical composition can adopt the conventional method of galenic pharmacy to prepare into tablet or capsule or drop pill.
8. the preparation method of a kind of pharmaceutical composition treating prostatic hyperplasia according to claim 5, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition treatment prostatic hyperplasia agents.
CN201610047112.1A 2016-01-25 2016-01-25 Pharmaceutical composition for treating prostatic hyperplasia Withdrawn CN105641217A (en)

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