CN105616987A - Pharmaceutical composition for preventing and treating prostatic hyperplasia and preparation method thereof - Google Patents

Pharmaceutical composition for preventing and treating prostatic hyperplasia and preparation method thereof Download PDF

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CN105616987A
CN105616987A CN201610047107.0A CN201610047107A CN105616987A CN 105616987 A CN105616987 A CN 105616987A CN 201610047107 A CN201610047107 A CN 201610047107A CN 105616987 A CN105616987 A CN 105616987A
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pharmaceutical composition
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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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Jinan Xingyi Medical Technology Co Ltd
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
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    • AHUMAN NECESSITIES
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Abstract

The invention discloses a pharmaceutical composition for preventing and treating prostatic hyperplasia and a preparation method thereof. The pharmaceutical composition is prepared from lowigite, aerides falcata, crateva unilocularis, auriculate dichrocephala herb or leaf and hydrangea xanthoneura root as raw medicines in proportion. The pharmaceutical composition can be prepared into various dosage forms according to the conventional preparation technology and has obvious curative effects on preventing and treating prostatic hyperplasia.

Description

Pharmaceutical composition of preventing and treating prostatic hyperplasia and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, particularly relate to a kind of pharmaceutical composition preventing and treating prostatic hyperplasia and preparation method thereof.
Background technology
Prostatic hyperplasia belongs to the category of the traditional Chinese medical science " essence is infirmity ", " difficulty in urination ". The name of the difficulty in urination, head see " Ling Shu Miraculous Pivot or Divine Axis. this is defeated " section: " three is burnt, the difficulty in urination actually, and void is incontinence of urine then ". Illustrate primary disease relevant with qiactivity of triple energizer function. And qiactivity of triple energizer function relies primarily on lung, spleen, kidney three is dirty maintains. The main water of kidney and take charge of urine, with bladder phase the exterior and the interior. Primary disease is multiple is born in middle-aged and elderly people, especially with more than 50 years old person for many. Its pathogenesis basis is kidney qi, kidney Yin bivacuity, and with deficiency of the kidney yin for this, damp and hot, blood stasis is mark, controls suitable nourishing kidney yin, eliminating damp-heat, blood circulation promoting and blood stasis dispelling. Being the basis that occurred of primary disease owing to suffering from a deficiency of the kidney, blood stasis is the pathology core of primary disease, often holds under the arm damp and hot in pathological process. Therefore Bushen Huayu damp eliminating through primary disease treat all the time. Thus consolidate that to radically reform be the principle for the treatment of of this disease. " Yizong Jinjian. Shan Buming hospital opinion " say " ZHU Dan-xi cloud: ' YIN often being in shortage, YANG often being in excess. Yi Changyangqiyin, cloudy neat with sun, then water can make fire, and this is anosis ' modern time people, desire person many, essence and blood both lost, and fire must be prosperous mutually, and Kidney-Yin healing exhausts, the positive absurd row of orphan, so common people's hyperactivity of fire causes this patient, ten residences eight or nine, fire declines into this disease person, the two or three of ten ". Benign prostate hyperplasia (BPH), it is called for short prostatic hyperplasia, it it is a kind of special Histopathologic disease, its feature shows as the hypertrophy of smooth muscle and fibrous tissue, the commonly encountered diseases causing elderly men lower urinary tract obstruction because of one of, clinically with Progressive symmetric erythrokeratodermia frequent micturition, dysuria for characteristics of incidence. Along with China's aged tendency of population, BPH also gets more and more, and becomes the common disease of elderly men, has a strong impact on the physical and mental health of old people.
Herba Dichrocephalae auriculatae: this product is the herb of Compositae Dichrocephala plant Herba Houttuyniae Dichrocephalaauriculata (Thunb.) Druce [EthuliaauriculataThunb.]. Summer, autumn gather, and dry. [nature and flavor] bitter in the mouth; Pungent; Property is put down. [function cures mainly] promoting blood flow to regulate menstruation; Removing toxic substances and promoting subsidence of swelling. Main menoxenia; Sprain and swell and ache; Furunculosis; Venom. [former phytomorph] Herba Houttuyniae annual herb, high 15-50cm. Stem is upright or paving is scattered, without hair or by pubescence. Blade is avette, oval or lanceolar, long 3-10cm, and major part plumage splits, and capping sheet is roomy, the wide 4cm that reaches, normal 1 pair of side sliver, and rare 2 pairs, two sides is without hair or by sparse pubescence. Head inflorescence is minimum, spherical, and diameter is about 5mm, is born in dichotomy top, and most head inflorescences line up loose umbrella room shape on stem top or branch top; Stalk is up to 3cm; Phyllary 1-2 layer; Holder semicircle spherical protuberances, above holds level with both hands; Disc floret both sexes; Can educate; Corolla tip has 4-5 tooth. Achene is flat, has the edge of thickening; Without pappus. Late summer at florescence is at the beginning of the winter. Record in Chinese medicine voluminous dictionary.
Fibroferritum: this product is the Ore of Sulfates mineral fibroferritum Fibrofessite. [nature and flavor] acid; Puckery; Salty; Cold; Poisonous. [return through] liver; Large intestine channel. [function cures mainly] removing toxic substances parasite killing; Sore. Main hemorrhoid complicated by anal fistula; Malignant boil; Scabies; Ear comes to a head. [character] this product is many in irregular bulk. Faint yellow. Sub-translucent; Silky lustre or pearly luster. Body is relatively light, and hardness is bordering on fingernail. Micro-have rust gas, and salty in the mouth, acid are micro-puckery. Yellowish with color, glossy, free from admixture person is preferred. [chemical analysis] main sulfur acid ferrum (Fe2O3��2SO3��10H2O), wherein sulfur trioxide (SO3) 32%, iron sesquioxide (Fe2O3) 32%, water (H2O) 36%. [original shape state] monoclinic system. Crystallization person is rare, is often the aggregation of fiber fines shape. Color is yellowish. Gloss is spun silk shape or Margarita shape. Sub-translucent. Hardness 2-2.5. Proportion 1.8-1.9. Record in Chinese medicine voluminous dictionary.
Fingernail is blue: this product is the orchid family Calanthe plant short stem calyx ridge orchid Sedireasubparishii(Tsi) herb of E.A.Chr. [HygrochilussubparishiiTsi]. The whole year all can adopt, using fresh herb. [nature and flavor] bitter in the mouth; Cool in nature. [function cures mainly] clearing heat for calming endogenous wind. Main infantile convulsion wind. [former phytomorph] short stem calyx ridge is blue, perennial evergreen draft of growing nonparasitically upon another plant. Stem short and oblique on, pleat phyllopodium is surrounded, grow thickly aerial root in bottom. Aerial root is sturdy and grows, bending, and white, without hair. 3-5 piece of leaf, 2 row, slightly meat, Long Circle or oval shape lanceolar, long 6-12cm, wide 2-3.5cm, tip blunt or tiltedly and 2 shallow split, base portion narrows embraces a stem, has linear slit cylindrarthrosis, and middle veinclearing shows. Scape 1-4, it is born in basal part of stem axil; The long 5-17cm of raceme, dredges remaining of raw flower 4-10; Petal sheet oval, long 7-12mm, wide 3-9mm, the blunt circle of tip; Flower pistac; Sepal is closely similar with petal, oblong, long 18-20mm, the widest part width 7-9mm, and slightly meat is carried out, and has 7, arteries and veins, the anxious point of tip, and middle sepal is slightly wider, and side sepal and petal are narrower, helps the carinate wing of tool in the sepal back side; Lip 3 splits, middle sliver meat, long and narrow circle, long 8-10mm, wide about 2mm, has the gusset of 1 piece high about 1.5mm from base portion to tip, and side sliver is upright, and semicircular edge has micro-tooth, has 1 piece of coniform corpus callosum from mouth place; Elongation shape, is about 1cm, slightly arc, to extension; Stamen column length 13-15mm, has stamen shape wing, and rostellum elongation 2 is split, and rostellum handle tip expands; Stick to the pan circle. Capsule oblong, even handle is about 7cm. The month at florescence 5-6, fruit phase JIUYUE. Record in Chinese medicine voluminous dictionary.
Hydrangea xanthoncura Diels root: this product is the root of Saxifragaceae hydrangea plant Huang arteries and veins silk ball HydrangeaxanthoneuraDiels. [nature and flavor] are pungent, temperature. [function cures mainly] blood circulation promoting and blood stasis dispelling, reunion of bone. Cure mainly fracture, rheumatic lumbago. [character] root is cylindrical, distortion, is about 8cm or longer, and diameter is about 2mm. Surface taupe, has vertical wrinkle and radicula or root trace. Crust is easy to fall off, and the place that comes off is aobvious faint yellow. Matter is tough, and difficulty fractures, section yellow-white, fibroid. Feeble QI, acrid in the mouth. Record in Chinese medicine voluminous dictionary.
Tree head dish: this product is the stem of Capparidaceae barna platymiscium tree head dish CratevaunilocularisBuch.Ham. [C.religiosaauct.nonForst.f.], leaf. [nature and flavor] bitter in the mouth; Cold in nature. [function cures mainly] heat-clearing and toxic substances removing; Stomach invigorating. Main acute filthy disease generates heat; Rotten skin ulcer; Venom; Stomachache; Rheumatic arthritis. [former phytomorph] sets head dish, and stingless arbor of falling leaves, up to more than 10m. Finger-like compound leaf; Tool long handle; 3 pieces of lobule, avette or ovum shape lanceolar, long 7-12cm, wide 3-5cm, tip is anxious sharp or tapering, and back of the body celadon corymb top is raw; Hua great, polygamy, diameter 5-7cm, first green-yellow, rear thin out purple; Sepal 4, bottom and floral disc bonding; Petal 4, avette or square is circular, tip is blunt or short point, has handle; Stamen is countless, with the base portion symphysis of podogynium; Ovary tool handle, Room 1. Berry is subsphaeroidal, diameter 2.5-4cm. Seed is most. The month at florescence 3-4, fruit month phase 7-8. Record in Chinese medicine voluminous dictionary.
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 preventing and treating 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 preventing and treating prostatic hyperplasia be:
Fibroferritum 30-40 weight portion fingernail orchid 6500-6600 weight portion tree head dish 3300-3500 weight portion Herba Dichrocephalae auriculatae 2080-2100 weight portion Hydrangea xanthoncura Diels root 1500-1600 weight portion.
It is preferably used in the pharmaceutical composition of preventing and treating prostatic hyperplasia, is prepared by the crude drug composition of weight portion:
Blue 6550 weight portion tree head dish 3400 weight portion Herba Dichrocephalae auriculatae 2090 weight portion Hydrangea xanthoncura Diels root 1550 weight portions of fibroferritum 35 weight portion fingernail.
A kind of pharmaceutical composition preventing and 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 preventing and treating prostatic hyperplasia, it is characterised in that the preventing and treating prostatic hyperplasia agents that pharmaceutical composition forms with chemical drugs or Chinese medicine.
The preparation method of a kind of pharmaceutical composition preventing and treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: fibroferritum 30-40 weight portion fingernail orchid 6500-6600 weight portion tree head dish 3300-3500 weight portion Herba Dichrocephalae auriculatae 2080-2100 weight portion Hydrangea xanthoncura Diels root 1500-1600 weight portion;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
The preparation method of preferred a kind of pharmaceutical composition preventing and treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: blue 6550 weight portion tree head dish 3400 weight portion Herba Dichrocephalae auriculatae 2090 weight portion Hydrangea xanthoncura Diels root 1550 weight portions of fibroferritum 35 weight portion fingernail;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% 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 preventing and 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 preventing and treating prostatic hyperplasia, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition preventing and treating prostatic hyperplasia agents.
Pharmaceutical composition preventing and treating prostatic hyperplasia is evident in efficacy.
Detailed description of the invention
Embodiment 1: pharmaceutical composition of preventing and treating prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be: fibroferritum 35g fingernail orchid 6550g tree head dish 3400g Herba Dichrocephalae auriculatae 2090g Hydrangea xanthoncura Diels root 1550g;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 2: pharmaceutical composition of preventing and treating prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be: fibroferritum 30g fingernail orchid 6600g tree head dish 3300g Herba Dichrocephalae auriculatae 2100g Hydrangea xanthoncura Diels root 1500g;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% ethanol elution, reclaim ethanol, concentrate drying, obtain extract B,
(3) extract A and extract B are mixed, obtain pharmaceutical composition.
Embodiment 3: pharmaceutical composition of preventing and treating prostatic hyperplasia and preparation method thereof
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be: fibroferritum 40g fingernail orchid 6500g tree head dish 3500g Herba Dichrocephalae auriculatae 2080g Hydrangea xanthoncura Diels root 1600g;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% 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 355g, adds starch 255g, mixing, granulates, dry, adds microcrystalline Cellulose 124g, magnesium stearate 6g, and mixing is pressed into 1500, obtains medicinal composition tablets.
Embodiment 5: the preparation of capsule
Example 2 pharmaceutical composition 357g, adds starch 246g, 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 200g water-bath (80 DEG C) heating and boil molten, add embodiment 3 pharmaceutical composition 21g, 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 2.0cm from liquid level, drips speed with per minute 60 for optimum condition, blot the condensing agent on drop pill surface with cotton, obtain medicament composition dropping pills.
Embodiment 7: the pharmaceutical composition of preventing and treating prostatic hyperplasia
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be:
Blue 1098 weight portions of tree head dish 6480 weight portion Herba Dichrocephalae auriculatae 3325 weight portion fingernail.
Embodiment 8: the pharmaceutical composition of preventing and treating prostatic hyperplasia
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be:
Tree head dish 5000 weight portion Herba Dichrocephalae auriculatae 3346 weight portion Hydrangea xanthoncura Diels root 290 weight portion.
Embodiment 9: the pharmaceutical composition of preventing and treating prostatic hyperplasia
The composition of crude drug and the weight portion of the pharmaceutical composition of preventing and treating prostatic hyperplasia be:
Tree head dish 3470 weight portion Herba Dichrocephalae auriculatae 3240 weight portion Hydrangea xanthoncura Diels root 608 weight portion.
Experimental example 1: the experimental study of preventing and treating prostatic hyperplasia
1 clinical data
1.1 physical data
33 example cases are the court's clinic case. 63 ~ 64 years old mean age, max age 81 years old, minimal ages 52 years old. (1) diagnostic criteria of BPH is met. (2) traditional Chinese medical science damp-heat accumulation and the CM syndrome differentiation criterion of addiction essential resistance of turbid are met. (3) refusal operative treatment. (4) tested voluntarily. (5) age was more than 50 years old (including 50 years old). All patients are randomly divided into treatment group and matched group, treatment group 16 example, matched group 17 example. Two groups of case equal no difference of science of statistics (P > 0.05) in age structure, the state of an illness etc.
1.2 TCM syndrome diagnostic criterias
Syndrome of accumulated dampness-heat: (1) frequent micturition, urgent micturition; (2) urine effort; (3) urine amount is short red scorching hot less; (4) perineal position is moist; (5) little distention and fullness in the abdomen, bitter taste mouth glues; (6) red tongue, yellow and greasy fur, stringy and rolling pulse. Addiction essential resistance of turbid demonstrate,prove: (1) urine drop and under; (2) urine is such as fine rule; (3) little distention and fullness in the abdomen or pain; (4) touch prostate increase, hardening; (5) purplish tongue secretly or has addiction point, thready and hesitant pulse. If possess syndrome of accumulated dampness-heat hold concurrently addiction essential resistance of turbid demonstrate,prove any two persons, be diagnosed as the turbid card of damp and hot addiction.
2 Therapeutic Method
Treatment group adopts pharmaceutical composition (implementing 1 pharmaceutical composition lot number 20140213) treatment. Method of administration: oral, each 0.8g, every day 3 times. Matched group gives prostate jindan sheet, each 4, oral, every day 3 times.
3 observation of curative effect
3.1 diagnostic criterias
The diagnostic criteria of Main Basis " People's Republic of China's traditional Chinese medicine industry standard ". The curative effect determinate standard of chronic hyperplasia of prostate, and change to some extent according to practical situation. Clinical healing in the recent period: clinical cardinal symptom disappears substantially, and Rectal tonch checks prostate, ultrasound diagnosis prostate volume<1 degree of hypertrophy standard, without residual urine volume, uroflometry>16ml/s; Effective: clinical cardinal symptom basic solution removes, raising more than 5ml/s per second on urinary flow basis before the treatment, anus examining finger veins is examined inspection prostate and is reduced than before treatmentMore than degree, ultrasound diagnosis prostate volume reduces 5mm than before treatment3Above, residual urine volume is than reducing more than 50ml before treatment; Effective: clinical cardinal symptom alleviates, raising 2 ~ 5ml/s per second on urinary flow basis before the treatment, anus examining finger veins is examined inspection prostate ratio and is reduced less than 1 degree before treatment, and ultrasound diagnosis prostate volume reduces 2 ~ 5mm than before treatment. Residual urine volume is than reducing below 50ml before treatment; Invalid: symptom, sign are without any improvement.
3.2 statistical method
Measurement data t checks, enumeration data X 2 test, and ranked data Ridit analyzes, and P < 0.05 is for there being significant difference.
3.3 therapeutic outcomes
Treatment group 16 example, cures 4 examples, effective 5 examples, effective 6 examples, invalid 1 example, effective percentage 93.75%; Matched group 17 example, cures 2 examples, effective 4 examples, effective 7 examples, invalid 4 examples, effective percentage 76.47%. Treatment group compares with matched group effective percentage, has significant difference (P < 0.05).
Symptom of urinating improvement is compared: symptom score of urinating carries out with reference to international contest IPSS, and result is as shown in table 1, and treatment group symptom integral relatively matched group after treatment has significance to improve.
Table 1 is urinated integral contrast (x �� s) before and after symptom treatment
Group n Before treatment After treatment
Treatment group 16 4.44��1.86 1.11��1.06*
Matched group 17 4.51��1.92 1.77��1.13
Note: compare with matched group, * P < 0.05.
It is shown that medicine composite for curing benign prostate hyperplasia truly has curative effect. Meanwhile, treatment group also superior to matched group, and does not have untoward reaction to occur over the course for the treatment of in symptom improvement of urinating.

Claims (8)

1. the pharmaceutical composition preventing and treating prostatic hyperplasia, it is characterised in that composition and the weight portion of making the crude drug of this pharmaceutical composition be:
Fibroferritum 30-40 weight portion fingernail orchid 6500-6600 weight portion tree head dish 3300-3500 weight portion Herba Dichrocephalae auriculatae 2080-2100 weight portion Hydrangea xanthoncura Diels root 1500-1600 weight portion.
2. a kind of pharmaceutical composition preventing and 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:
Blue 6550 weight portion tree head dish 3400 weight portion Herba Dichrocephalae auriculatae 2090 weight portion Hydrangea xanthoncura Diels root 1550 weight portions of fibroferritum 35 weight portion fingernail.
3. a kind of pharmaceutical composition preventing and 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 preventing and treating prostatic hyperplasia according to claim 1, it is characterised in that the preventing and treating prostatic hyperplasia agents of pharmaceutical composition and chemical drugs or Chinese medicine composition.
5. the preparation method of the pharmaceutical composition preventing and treating prostatic hyperplasia, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: fibroferritum 30-40 weight portion fingernail orchid 6500-6600 weight portion tree head dish 3300-3500 weight portion Herba Dichrocephalae auriculatae 2080-2100 weight portion Hydrangea xanthoncura Diels root 1500-1600 weight portion;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% 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 preventing and treating prostatic hyperplasia according to claim 5, it is characterised in that prepare as follows:
The composition of crude drug and weight portion be: blue 6550 weight portion tree head dish 3400 weight portion Herba Dichrocephalae auriculatae 2090 weight portion Hydrangea xanthoncura Diels root 1550 weight portions of fibroferritum 35 weight portion fingernail;
Preparation method:
(1) fibroferritum is taken by crude drug proportioning, fingernail is blue, tree head dish, Herba Dichrocephalae auriculatae, Hydrangea xanthoncura Diels root, mixing, with weight percent concentration 14% ethanol as solvent, extract at 26 DEG C of warm macerating, extraction time is 16 times, each extraction time is 9 hours, each solvent load is 41 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 1.08, filter, medicinal liquid passes through DM11 macroporous adsorptive resins, first wash with water, again with weight percent concentration 66% alcoholic solution eluting DM11 macroporous adsorptive resins, collect weight percent concentration 66% ethanol elution, reclaim ethanol, concentrate drying, obtain extract A,
(2) step (1) medicinal residues A is taken, with weight percent concentration 42% ethanol as solvent, heating and refluxing extraction 18 times, each extraction time is 0.5 hour, each solvent load is 35 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 D980 macroporous adsorptive resins, first wash with water, again with weight percent concentration 73% alcoholic solution eluting D980 macroporous adsorptive resins, collect weight percent concentration 73% 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 preventing and 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 preventing and treating prostatic hyperplasia according to claim 5, it is characterised in that pharmaceutical composition and chemical drugs or Chinese medicine composition preventing and treating prostatic hyperplasia agents.
CN201610047107.0A 2016-01-25 2016-01-25 Pharmaceutical composition for preventing and treating prostatic hyperplasia and preparation method thereof Withdrawn CN105616987A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106692275A (en) * 2016-12-10 2017-05-24 济南昊雨青田医药技术有限公司 Pharmaceutical composition for preventing amygdalitis and preparation method of pharmaceutical composition

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106692275A (en) * 2016-12-10 2017-05-24 济南昊雨青田医药技术有限公司 Pharmaceutical composition for preventing amygdalitis and preparation method of pharmaceutical composition

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