CN101912448A - Medicinal composition for treating benign prostatic hyperplasia, and preparation method and use thereof - Google Patents
Medicinal composition for treating benign prostatic hyperplasia, and preparation method and use thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for treating benign prostatic hyperplasia, which is a preparation prepared from the following crude medicaments in part by weight: 15 to 45 parts of epimedium, 15 to 45 parts of turtle shell, 5 to 15 parts of baical skullcap root and 7.5 to 22.5 parts of plantain herb. The invention also provides a preparation method and use of the medicinal composition. The medicinal composition has the effects of tonifying kidney, strengthening yang, clearing heat, promoting diuresis and dissipating binds, is used for the benign prostatic hyperplasia with the symptoms of frequent urination and yellow red urine, especially at night, small urinary stream, disturbance in urination, vesical tenesmus or dropwise urination, even urodialysis, urine filling the lower abdomen, and the like, and has the characteristics of approved curative effect, safety, convenience, no toxic or side effect and low cost.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of benign prostate hyperplasia, belong to drug world.
Background technology
Benign prostate hyperplasia (Benign Prostatic Hyperplasia, BPH) be a kind of be common male's Senile disease of main clinical characteristics with the dysuria.Along with prostate transitional areas proliferation of cells, prostate volume constantly increases, thereby the compressing prostatic urethra causes that the wing skin is outlet obstructed, cause the patient in various degree symptoms such as dysuria to occur, severe patient urinary tract hydrops can occur on the bilateral and cause renal insufficiency.BPH morbidity and race, regional relevant, American-European countries's sickness rate is higher than the Asia, though the sickness rate of China BPH is lower than American-European countries, along with social population's aging, the incidence rate of BPH also increases year by year.Yu Pulin etc. show that to the 3361 example Epidemiological studys that the old people carries out more than 60 years old the prostate total prevalence rate is 43.68%, at present the ill level of approaching American-European flourishing consanguinity.Therefore, BPH has a strong impact on China's elderly men commonly encountered diseases of quality of life, frequently-occurring disease.Therefore, as the male senile patient commonly encountered diseases, hyperplasia of prostate has had a strong impact on the life and the quality of life of elderly men.Along with the raising of living standards of the people and the progress of health care, aging population increase day by day, the also corresponding increase of the case load of BPH, cause at urinary tract and to block, influence is urinated, and directly threaten renal function, and incidence and mortality rises constantly, bring serious harm for old people's life and health, BPH is the clinical important topic of andrology.
Chinese medicine does not have this name of disease of prostatic hyperplasia, should belong to disease categories such as " difficulty in urination ", " dysuria " according to its clinical manifestation.The pathogenesis of prostatic hyperplasia is very complicated, but neither irregularly follow.By studying lot of documents and combination clinical practice experience for many years at all times, think that the pathogenic characteristic of prostatic hyperplasia is (kidney qi the is lost empty) excess of the liver (the tired blood of Liver Channel, turbid, the dampness-heat of the liver of Liver Channel expectorant) of suffering from a deficiency of the kidney, simulataneous insufficiency and excessive, " excess of the liver of suffering from a deficiency of the kidney " is its basic pathogenesis.Prostate belongs to Chinese medicine " smart chamber " category, and smart chamber is the important component part of external genitals, and kidney is had one's ideas straightened out in the external genitalia, and Liver Channel is around external genitals, so the internal organs of prostatic hyperplasia are positioned at the kidney liver.The kidney being the origin of congenital constitution, main growth promoter.Kidney qi is filled Sheng, can preside over growth promoter, and then the prostate growth promoter is normal; Asthenia of renal qi can not be presided over growth promoter, then prostate growth failure and see hypertrophy.It is capable that the deficiency of vital energy can not promote Tianjin blood cloth, and wine is given birth to damp and hot, and consor expectorant is tired, the stagnant Liver Channel of knot, thus increase the weight of prostatic hyperplasia.Suffering from a deficiency of the kidney, to cause misgrowth of prostate body of gland and excess of the liver to cause unusual increase of prostate body of gland be the two big pathomechanisms that constitute the prostatic hyperplasia morbidity, and the excess of the liver of suffering from a deficiency of the kidney, simulataneous insufficiency and excessive are the basic pathogenesis of prostatic hyperplasia.
At present, the Therapeutic Method of hyperplasia of prostate is a lot, mainly contains two kinds of operative treatment and nonoperative interventional therapies.
Summary of the invention
Technical scheme of the present invention provides a kind of pharmaceutical composition for the treatment of benign prostate hyperplasia.Another technical scheme of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition for the treatment of benign prostate hyperplasia, it is the medicament that is prepared from by following raw materials by weight proportions:
Herba Epimedii 15-45 part, Carapax Trionycis 15-45 part, Radix Scutellariae 5-15 part, Herba Plantaginis 7.5-22.5 part.
Further preferably, it is the medicament that is prepared from by following raw materials by weight proportions:
30 parts of Herba Epimedii, 30 parts of Carapax Trionycis, 10 parts of Radix Scutellariaes, 15 parts of Herba Plantaginiss.
Pharmaceutical composition of the present invention is to be active component by water of Herba Epimedii, Carapax Trionycis, Radix Scutellariae, Herba Plantaginis or extractive with organic solvent, adds acceptable accessories or complementary composition and is prepared into medicament pharmaceutically commonly used.
Wherein, described medicament is tablet, capsule, pill, granule, oral liquid.
The present invention also provides the method for preparing this pharmaceutical composition, and it comprises the steps:
A, get raw material: Herba Epimedii, Carapax Trionycis, Radix Scutellariae, Herba Plantaginis;
B, get Herba Epimedii, Radix Scutellariae, Herba Plantaginis; Add the 70-80% alcoholic solution, decoct and extract, filter, filtrate concentrates;
C, get Carapax Trionycis, decoct with water, filter, filtrate concentrates;
D, the concentrated solution of b and c step is mixed, add acceptable accessories or complementary composition and be prepared into preparation pharmaceutically commonly used.
Wherein, the described concentration of alcohol of b step is 70%.
The present invention also provides the purposes of this pharmaceutical composition in the medicine of preparation treatment benign prostate hyperplasia.
BPH belongs to the traditional Chinese medical science " difficulty in urination " category according to its clinical manifestation, and the prostate body of gland that promptly increases according to its partial pathological change belongs to traditional Chinese medical science “ mass in the abdomen " scope.The traditional Chinese medical science is thought the site of pathological change of BPH at bladder, and pathogeny is wet for the folder stasis of blood folder of suffering from a deficiency of the kidney.The kidney yang deficiency of vital energy, disturbance in functioning of QI, water retention is wet poly-, channels is obstructed, dysfunction of the urinary bladder, thus see the urine line attenuate, urinate waits, urinate diseases such as flowing interruption, the bifurcated of urinating.Method of treatment such as clinical employing the kidney invigorating damp eliminating obtain clinical efficacy preferably.
Medicinal granule of the present invention is the summary of clinical many years of experience, forms the Herba Epimedii sweet in the mouth by Herba Epimedii, Carapax Trionycis, the Radix Astragali, Semen Plantaginis four flavor Chinese medicines, warm in nature, return liver, kidney channel, have the effect of warming the kidney to invigorate YANG, beneficial smart Conclusion Decreasing, modern study thinks that the main effective ingredient of Herba Epimedii is a Herba Epimedii total flavones, has the effect of androgen sample, energy human body immunity improving function, can expand peripheral blood vessel, microcirculation improvement, blood flow increasing, reduce Peripheral resistance, increase coronary flow.Carapax Trionycis, salty-cold, return liver, kidney channel, nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving is the in love thing of flesh and blood, having again jumps attacks the property of dashing, and can go deep into the tunnel network, attacks the stasis of blood resistance of picking chronic knot, the moving gas of rotation sun, and Carapax Trionycis is broken and not high, can manage it can and, people's use of suitable aged debility; Radix Scutellariae, bitter cold is returned lung, stomach, gallbladder, large intestine channel, and heat clearing and damp drying is an adjuvant drug, and Herba Plantaginis is sweet and sliding sharp, and cold and cool heat clearing away has the merit of inducing diuresis for treating stranguria syndrome, is messenger drug.Full side four medicines share the basic pathogenesis of the primary disease that can link closely, and treating both the principal and secondary aspects of a disease is mended clear double the executing of living, and heresy is not stayed in the kidney invigorating, not eliminating evil just the wound, and synergism is played liver and kidney tonifying altogether, the effect of clearing away heat-damp and promoting diuresis eliminating stagnation.
Medicine of the present invention has kidney invigorating and YANG supporting, the effect of clearing away heat-damp and promoting diuresis eliminating stagnation.Be used for hyperplasia of prostate, disease sees that the frequent micturition Huang is red, and night, more so the urine line attenuated, and it is not smooth to urinate, the heeltap not to the utmost, or drop is not well, very then urine retention is obstructed, diseases such as lower abdomen distension.Curative effect of medication of the present invention is definite, safe ready, have no side effect, cheap.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Description of drawings
The pathomorphology that Fig. 1-6 respectively organizes the prostata tissue section changes
Fig. 1 normal group (* 40) wherein
Fig. 2 BPH model group (* 40)
Fig. 3 proscar treatment group (* 40)
Fig. 4 medicine low dose group of the present invention (* 40)
Dosage group (* 40) in Fig. 5 medicine of the present invention
Fig. 6 medicine high dose group of the present invention (* 40)
The specific embodiment
The preparation of embodiment 1 medicinal granule of the present invention
1, medicine is formed
Herba Epimedii 30g (monarch drug), Carapax Trionycis 30g (ministerial drug), Radix Scutellariae 10g (adjuvant drug), Herba Plantaginis 15g (messenger drug)
Former decoction: adult's (pressing the 60kg body weight calculates) measures and amounts to 85g one pair of every day; Sooner or later respectively fry in shallow oil once.
The extraction process of 2 medical materials:
(1) alcohol extraction group technology:
Get recipe quantity multiple Herba Epimedii, Radix Scutellariae, Herba Plantaginis; Add 12 times of medical material amount 70% alcoholic solutions, extracted 1.5 hours, extract three times, (with 6-8 layer gauze) filtered while hot, putting and being concentrated into relative density in the Rotary Evaporators is 1.0, it is standby to put refrigerator.
(2) water is put forward group technology:
Get recipe quantity multiple Carapax Trionycis, pulverize, cross 24 mesh sieves; Add 10 times of water, each 3 hours (time picking up counting from boiling) extracts twice; Filtered while hot is concentrated into relative density 1.1.
3 purifying process
Get alcohol extraction group concentrated solution, slowly add distilled water, the limit edged stirs, and makes it contain the alcohol amount and reduces to 50%, leave standstill 24 hours after, centrifugal 20 minutes, (rotating speed is 3000r/min) discards the lower sediment thing, obtains supernatant, and be standby.
4 drying process with atomizing
The water extracting liquid and the above-mentioned purification supernatant of Carapax Trionycis are mixed, be concentrated into relative density 1.1, under 76～80 ℃ of conditions of 142～150 ℃ of leaving air temps of inlet temperature, carry out spray drying.
5 moulding processs
Get spray powder and adjuvant, proportionally (spray powder: soluble starch: microcrystalline Cellulose=5: 3: 2).Mix, add 85% ethanol, wet granulation, drying, granulate promptly gets medicinal granule of the present invention.
The preparation of embodiment 2 medicinal tablets of the present invention
Get crude drug: Herba Epimedii 45g, Carapax Trionycis 15g, Radix Scutellariae 15g, Herba Plantaginis 7.5g, press the method system granule of embodiment 1, add magnesium stearate, tabletting is prepared into tablet.
The preparation of embodiment 3 medicine oral liquids of the present invention
Get raw material Herba Epimedii 15g, Carapax Trionycis 15g, Radix Scutellariae 15g, Herba Plantaginis 22.5g, press the method for embodiment 1 and extract, be prepared into oral liquid behind the purification.
Below prove beneficial effect of the present invention by pharmacodynamics test.
Test example 1 medicinal granule treatment BPH rat observation of curative effect of the present invention
1 material
1.1 animal: 60 of SPF level male SD rats, body weight 210～230g, Shanghai Slac Experimental Animal Co., Ltd. provides, quality certification SCXK2007-0005.
1.2 medicine: (Shanghai General Pharmaceutical Co., ltd. produces 25mg/ml Testosterone Propionate injection, lot number: H31020524); (Mo Shadong drugmaker in Hangzhou produces proscar 5mg, lot number: J20050041); Medicinal granule of the present invention: (development of department of pharmacy of Colleges Of Traditional Chinese Medicine Of Fujian); Testosterone, estradiol, bFGF, EGF,
VEGF, radioimmunoassay, RIA medicine box; Trizol (invitrongen company); DNTP, RT test kit (Pronmag company); Tag polymerase, Rnasc inhibitor (TakaRa company); Primer is synthetic by the handsome biological company limited in Shanghai.
1.3 instrument: electronic analytical balance (Shanghai balance equipment factory); Binocular optical microscope (Japanese Olympus company); DU-640 type protein nucleic acid analyser (U.S. Beckman company); 5417R High speed refrigerated centrifuge (German Eppendorf company); 9600 type PCR instrument (PE company); Gel DOC2000 type gel imaging analysis system, APC 300 type electrophresis apparatuses, horizontal strip electrophoresis groove (Bio-Rad company); DU-650 type protein nucleic acid analyser (Beckman company).
2 methods
2.1 the preparation of prostatic hyperplasia rat animal model:
60 of SPF level male SD rats, ketamine 100mg/kg intraperitoneal injection of anesthesia through the capable aseptic operation of scrotum, is extractd bilateral testes, recovered for 1 week after, every subcutaneous injection Testosterone Propionate 5mg/kg, 30d weighs weekly 1 time continuously.
2.2 medication and drawing materials:
After the modeling success, when continuing the injection modeling, each organizes rat, and except that blank group and pathological model group rats gavaged normal saline, all the other each groups are according to the corresponding dosage administration, and dosage is respectively: blank group, pathological model group normal saline 10ml/kg.d
-1, proscar group 0.5mg/kg.d
-1(be equivalent to clinical people's dosage 6 times), medicinal granule low dose group 3g/kg.d of the present invention
-1Dosage group 6g/kg in (be equivalent to clinical application amount 3 times), the medicinal granule of the present invention
-1.d
-1(be equivalent to clinical application amount 6 times), medicinal granule high dose group 12g/kg of the present invention
-1.d
-1(be equivalent to clinical application amount 12 times) (by embodiment 1 preparation), more than all adopt gastric infusion 1 time/day, 30d (during the administration, weighing weekly) continuously once to adjust dosage.Fasting is 24 hours behind the last filling stomach, and each Mus is weighed (g), and the anesthesia abdominal aortic blood is isolated complete prostata tissue, and carefully it intactly taken out, and measures prostate weight in wet base and volume, calculates the prostate index; Get each one of the prostata tissue of same area, liquid-solid calmly to be measured with 10% formalin fixed; Get 50～100mg prostata tissue and be stored in the liquid nitrogen, to be measured.
3 observation index and testing result
3.1 the prostate index is measured the prostata tissue weight in wet base with analytical balance; The volumetric method measurement volumes; Calculate prostate index (PI) PI=prostate weight in wet base/body weight); Body weight (seeing Table 1-2) before rat body weight-modeling before rat body weight value added=execution.
Table 1 is respectively organized the comparison of rat experiment front and back body weight and weight increase
Table 2 is respectively organized the exponential comparison of rat prostate weight in wet base, volume and prostate
Annotate: compare 1 with normal group) P＜0.01; Compare 2 with model group) P＜0.01,3) P＜0.05
Each organizes rat body weight does not have significant difference, shows that poisonous side effect of medicine of the present invention is less; Prostate weight in wet base and prostate volume and prostate index reduce than model group and reduce in the medication therapy groups of the present invention, show medication effect of the present invention, but dose-effect relationship do not have significant difference in the treatment group.
3.2 prostata tissue morphological observation
Pathomorphism (light microscopic) is got prostate siphonal lobe same area prostata tissue, 10% formalin fixed, and conventional haematoxylin Yihong (HE) dyeing, the pathomorphology that light microscopic is observed the prostata tissue section down changes.
Normal group prostate smooth surface, organize pliable and tough flexible, clear with surrounding tissue organ boundary; Body of gland is arranged clearly under the light microscopic, and lumen of gland does not have expansion, glandular epithelium monolayer short cylinder or cube type, and smooth surface, secretions is few.The model group prostate volume obviously increases than normal group, and fragility is big, and with bladder and seminal vesicle tissue adhesion is arranged; Many and the dense arrangement of body of gland under the light microscopic, it is big that lumen of gland becomes, the expansion of part body of gland, secretions increase, the obvious hypertrophy of glandular epithelium is high column, and the subregion level increases, arrangement disorder, it is prominent to the outstanding indentation of intracavity that most glandular epithelium are mamillary, and a matter has hyperemia, calcification, connective tissue proliferation.Prostate volume in proscar group and medicinal granule of the present invention (high, medium and low dosage) group dwindles than model group, organizes inflammatory edema to alleviate, and quality is pliable and tough flexible, does not have obvious adhesion with surrounding tissue.Proscar group part lumen of gland becomes big under the light microscopic, and tube chamber cell DANFU layer occurs, and epithelial cell mostly is the monolayer column, and [obviously reduces; It is big that medicinal granule low dose group part lumen of gland of the present invention becomes, and tube chamber cell DANFU layer occurs, and epithelial cell is high column or the monolayer column has concurrently, and [reduces.The dosage group sees that lumen of gland obviously reduces in the medicinal granule of the present invention, and it is big that the fraction lumen of gland becomes, and the tube chamber cell mostly is the monolayer columnar arrangement, and small part is [; Medicinal granule high dose group of the present invention sees that the lumen of gland size is basic near consistent, and few lumen of gland becomes big, and the tube chamber cell mostly is the monolayer short cylinder and arranges, and does not have papillae substantially, and secretions is few, and a matter, fiber content slightly increase (seeing Fig. 1-6).
3.3 respectively organize serum T, E
2Content and E
2The comparison of/T ratio (seeing Table 3)
The comparison of hormone T, E2 content and T/E2 ratio in the table 3 pair rat blood serum
Annotate: compare 1 with normal group) P＜0.01; Compare 2 with model group) P＜0.01,3) P＜0.05
T/E in the rat blood serum
2Ratio, model of hyperplasia group and normal group be T/E relatively
2Obviously reduce the middle and high dosage group of medicinal granule of the present invention T/E
2Compare with the model of hyperplasia group, increase T/E2 with dosage and increase, middle and high dosage group obviously is dose-effect relationship.
3.4 respectively organize somatomedin in the serum (bFGF, EGF,
VEGF) comparison of content (seeing Table 4)
The comparison of somatomedin bFGF, EGF, TGF-β 1, VEGF content in the table 4 pair rat blood serum
Annotate: compare 1 with normal group) P＜0.01; Compare 2 with model group) P＜0.01,3) P＜0.05;
Each organize somatomedin in the serum (bFGF, EGF,
VEGF) bFGF, EGF, VEGF obviously reduce in,
Obviously increase.
3.5 respectively organize somatomedin in the prostata tissue (bFGF, EGF,
VEGF) comparison (seeing Table 5) of mRNA expression: VEGF, the EGF in the BPH rat prostate tissue, the mRNA of bFGF express significantly and raise, and
MRNA express significantly and reduce (with normal group relatively, P＜0.01 and P＜0.05).The results are shown in Table 5
VEGF, EGF in the table 5 pair rat prostate tissue, bFGF and
The comparison that mRNA expresses
Annotate: compare 1 with normal group) P＜0.01,2) P＜0.05; Compare 3 with model group) P＜0.01,4) P＜0.054 statistical procedures: The data
The t check is adopted in expression, with SPSS12.0 statistical software deal with data.
The clinical summary of test example 2 medicinal granule treatment prostatic hyperplasia 75 examples of the present invention
One, clinical data
1 diagnostic criteria: " the new Chinese medicine treatment benign prostate hyperplasia clinical guidance principle " standard of formulating and " benign prostatic hyperplasia diagnoses and treatment guide " of Urology Surgery association of Chinese Medical Association promulgation in 2009 in " new Chinese medicine clinical research guideline " (the 3rd volume) with reference to health ministry issue in 1997.
1.1 Western medicine diagnose standard
(1) dysuria, hesitate, urine thin is unable, waste time and energy, urinate stream interrupts;
(2) frequent micturition, nocturia frequency, very the person has urine retention or urinary incontinence;
(3) anus touch: two lateral lobes increase, smooth, flexible, Rolandic fissure shoals or disappears;
(4) ultrasound diagnosis: prostate increases, weight＞20g;
(5) uroflometry: urine amount＞150ml, Qmax Qmax＜15ml/s.If urine amount＜150ml should consider urine amount factor.As through making great efforts repeatedly, patient can not reach above standard, can adopt the Qmax result of existing urine amount;
(6) residual urine volume:, measure bladder and have or not residual urine through abdomen ultrasound diagnosis or urethral catheterization method.
All possess (1), (2), (3), (4), (5) or (6) the item person that holds concurrently, and can be diagnosed as benign prostate hyperplasia.
1.2 clinical stages standard
The 1st phase (irritation phase): bladder, urethra, perineum are slightly uncomfortable, frequent micturition, and slight dysuria mainly shows as the nocturia frequency, residual urine＜50ml.International prostate gland symptoms scoring (I-PSS)≤7 minute.
The 2nd phase (residual urine phase): carrying out property dysuria, conscious exerting oneself when urinating, residual urine volume 50-150ml, acute urinary retention, urinary tract infection can take place in this phase.I-PSS scoring 8-19 branch.
The 3rd phase (bladder loses the compensatory phase): residual urine volume＞150ml, bladder enlarges, and renal function begins impaired, the urinary retention with overflow incontinence symptom occurs.I-PSS scoring 20-35 branch.
1.3 state of an illness standards of grading
1.3.1 the international prostate gland symptoms of table 6 (I-PSS) point system
1.3.2 quality of life index (QOL) assessment method sees Table 7
The patient makes the evaluation of quality of life from now on by the situation of urinating now, estimates according to following standard according to it and provides quality of life index (QOL):
Table 7 quality of life index (QOL) evaluation form
1.4 Chinese medical discrimination standard:
(1) syndrome of dampness-heat diffusing downward
Main symptom: the frequent micturition Huang is red, urethra scorching hot or puckery pain, and it is not smooth to urinate, even drop is obstructed, little distention and fullness in the abdomen
Inferior card: be hard and dry, the bitter taste mouth is sticking
The tongue arteries and veins: tongue is dark red, yellow and greasy fur, slippery and rapid pulse or stringy and rapid pulse
(2) spleen syndrome of deficiency of kidney-QI
Main symptom: frequent micturition, the sound of rain pattering are not smooth, and the urine line is thin, even enuresis nocturna or urine retention are obstructed
Inferior card: spiritlessness and weakness, poor appetite, lusterless complexion, loose stool proctoptosis
The tongue arteries and veins: light red tongue, tongue is white, thready pulse without strength
(3) syndrome of qi stagnation and blood stasis
Main symptom: it is not smooth to urinate, and the urine line attenuates or drop and descend, or Urethra astringent pain, and obturation is obstructed
Inferior card: lower abdomen distension dull pain has hematuria once in a while
The tongue arteries and veins: body of the tongue is dim or the petechia ecchymosis is arranged, Tai Bai or BOHUANG, stringy pulse or puckery
(4) deficiency of kidney-YIN card
Main symptom: frequent micturition is not well, and oliguria heat is red, or inaccessible obstructed
Inferior card: dizziness and tinnitus, soreness of the waist and knees, dysphoria with feverish sensation in the chest palms and soles, constipation
The tongue arteries and veins: red tongue with a little fluid, tongue is few, thready and rapid pulse
(5) insufficiency of kidney-YANG card
Main symptom: frequent micturition, night, more so the urine line attenuated, the heeltap not to the utmost, or drop is not well, very then urine retention is obstructed
Inferior card: lethargy, lusterless complexion, aversion to cold and cold limbs
Tongue arteries and veins: pale and moist tongue, white and thin fur, stringy and thready pulse
The tcm symptom integration: light according to each tcm symptom of patient, in, heavy difference counted respectively 1,2,3 fen, the summation of each tcm symptom scoring is the tcm symptom integration.
1.5 include the case standard in
(1) meets doctor trained in Western medicine BPH diagnostic criteria, prostate volume＞20ml.
(2) meet the dialectical standard that traditional Chinese medical science stagnation of blood stasis or kidney yang deficiency are demonstrate,proved.
(3) age 50-80 year male.
(4) be the main object of observation with 1,2 phases (promptly light, moderate) patient.
(5) course of disease is more than three months.
(6) stop a
1Receptor blocking agent class medicine is more than one month or 5a reductase inhibitor and Chinese medicine person more than 6 months.
(7) Qmax＜15ml/s or AFR＜10ml/s.
1.6 get rid of the case standard
(1) oliguria or anuria due to lithangiuria, carcinoma of prostate, the acute or chronic renal failure.
(2) dysuria that causes of neurogenic bladder, neck of bladder fibrosis, urethral stricture.
(3) frequent micturition that causes such as gonorrhea, urinary tract infection.
(4) serious primary disease such as cardiovascular and cerebrovascular vessel, liver and hemopoietic system is arranged, intractable diabetes and diabetic neuropathy, psychotic are arranged.
(5) benign prostate blocks invasive treatment loser.
(6) there are operation on pelvis or damage history to influence functional status persons such as local internal organs, muscle, nerve, muscle.
(7) the B ultrasonic last urinary tract obstruction hydrops finding obvious diverticulum of bladder person or cause because of BPH, the impaired renal function person.
1.7 reject the case standard
(1) allergic constitution or to the trial drug allergy sufferers.
(2) or share other drug.
(3) all standards of including in that do not meet, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.
(4) tried the back compliance poor, serious adverse events takes place, should not continue to be subjected to examination, bolter automatically because of special physiological changes.
1.8 test is ended or is come off
Stop or the person of coming off test occurring, should investigate thoroughly reason and record, analyze the termination case simultaneously and may produce which kind of influence research conclusion.
(1) serious adverse events appears.
(2) serious merging disease appears in the process of the test.
(3) violate research approach.
(4) patient withdraws from test automatically or loses and visit
2 research methoies
2.1 reach grouping at random
Case be will include in by the prescription on individual diagnosis serial number, treatment group and matched group will be divided at random in 1: 1 ratio.
2.2 medicine and medication
2.2.2 treatment group: oral medicinal granule of the present invention (Drug Manufacturing Room of Zhongshan Hospital Xiamen University preparation), each one bag, every day three times, 12 weeks were 1 course of treatment, observed for 1 course of treatment.
2.2.3 matched group: proscar sheet (Proscar), specification 5mg/ sheet * 7 slice/box, every contains finasteride (Finasteride) 5mg, and Mo Shadong pharmaceutical Co. Ltd in Hangzhou provides, each 1 of medication, every day 1 time is oral, and 12 weeks were 1 course of treatment, observed for 1 course of treatment.
When carrying out Drug therapy, allow to adopt following treatment measure and points for attention: 1. bladder training.2. if urine retention (bladder residual urine volume＞400ml) feasible retention catheterization or suprapubic puncture fistulation drainage of urine occur.3. avoid and drink, the irritable food that avoids pungent food keeps free movement of the bowels, and is by bike not long-distance, adheres to regular life.
2.3 observation index
2.3.1 health giving quality index:
(1) related symptoms of primary disease and sign, picture of the tongue, pulse condition, prostate palpation.
(2) international prostate gland symptoms scoring (I-PSS), quality of life index (QOL), the tcm symptom integration is tested and assessed respectively 2 times, gets its meansigma methods.
(3) per rectum B ultrasonic method is measured prostate volume (TPV), is measured bladder residual urine volume (URV) through the Abdominal B type ultrasonography method.TPV=π (major diameter * wide * thick)/6.URV: behind the emptying bladder, under B ultrasonic, measure the transverse diameter and the thick footpath of bladder, survey major diameter, URV=(transverse diameter * thick footpath * major diameter) * 0.7 (this method is more accurate to residual urine＜200ml) with the median line tangent plane.
(4) urodynamics test: Ascend urodynamics detector (Laborie company) detects Qmax Qmax, AFR Qave, surveys respectively 2 times, gets its meansigma methods, and urine will be suitably suppressed in the inspection of urine flow rate, and becoming the Urina Hominis amount is good between 150-400ml.
2.3.2 safety and untoward reaction are observed
In observe the curative effect, note observing the toxic and side effects of safety and untoward reaction or medicine.
(1) three big routine, electrocardiogram, PSA, blood pressure and hepatic and renal function change.
(2) general reaction: feel sick, vomiting, erythra, other.
Should select relevant lab testing at concrete symptom when (3) untoward reaction occurring.
2.4 efficacy assessment standard
2.4.1 produce effects
(1) the I-PSS scoring≤7, QOL index≤1, or state of an illness total points reduces more than 90%;
(2) prostate volume is reduced into original below 60%;
(3) Qmax 〉=18ml/s.
More than possessing 2 gets final product.
2.4.2 effectively
(1) the I-PSS scoring≤13, and index QOL is reduced to 2-3 for 4-6 person before the treatment, or state of an illness total mark reduces more than 60%;
(2) prostate volume is reduced into originally below 80%, and residual urine volume reduces more than 50%;
(3) Qmax 〉=12ml/s
More than possessing 1 gets final product.
2.4.3 it is invalid: as not reach effective standard.
2.5 statistical method
Measurement data with
Expression, measurement data relatively adopts paired t-test, and ranked data relatively adopt rank test, and enumeration data relatively adopts Ri dit check.
3 results
Produce effects 50 examples, 66.7%; Effective 22 examples, 29.3%; Invalid 3 examples, 4%, total effective rate 96%.
Three, discuss
Clinical trial of the present invention is adopted according to the method investigation of the diagnostic criteria of " the benign prostatic hyperplasia diagnoses and treatment guide " that meet " People's Republic of China's Chinese medicine industry standard traditional Chinese medical science disease diagnosis criterion of therapeutical effect " and Urology Surgery association of Chinese Medical Association promulgation in 2009 and is commented.Benign prostate hyperplasia (Benign Prostatic Hyperplasia, BPH) be a kind of be common male's Senile disease of main clinical characteristics with the dysuria.Its pathogenic characteristic is (kidney qi the is lost empty) excess of the liver (the tired blood of Liver Channel, turbid, the dampness-heat of the liver of Liver Channel expectorant) of suffering from a deficiency of the kidney, simulataneous insufficiency and excessive, and " excess of the liver of suffering from a deficiency of the kidney " is basic pathogenesis.
Medicinal granule of the present invention is the summary of clinical many years of experience, forms the Herba Epimedii sweet in the mouth by Herba Epimedii, Carapax Trionycis, the Radix Astragali, Semen Plantaginis four flavor Chinese medicines, warm in nature, return liver, kidney channel, have the effect of warming the kidney to invigorate YANG, beneficial smart Conclusion Decreasing, modern study thinks that the main effective ingredient of Herba Epimedii is a Herba Epimedii total flavones, has the effect of androgen sample, energy human body immunity improving function, can expand peripheral blood vessel, microcirculation improvement, blood flow increasing, reduce Peripheral resistance, increase coronary flow.Carapax Trionycis, salty-cold, return liver, kidney channel, nourishing YIN for suppressing the hyperactive YANG, hard masses softening and resolving is the in love thing of flesh and blood, having again jumps attacks the property of dashing, and can go deep into the tunnel network, attacks the stasis of blood resistance of picking chronic knot, the moving gas of rotation sun, and Carapax Trionycis is broken and not high, can manage it can and, people's use of suitable aged debility; Radix Scutellariae, bitter cold is returned lung, stomach, gallbladder, large intestine channel, and heat clearing and damp drying is an adjuvant drug, and Herba Plantaginis is sweet and sliding sharp, and cold and cool heat clearing away has the merit of inducing diuresis for treating stranguria syndrome, is messenger drug.Full side four medicines share the basic pathogenesis of the primary disease that can link closely, and treating both the principal and secondary aspects of a disease is mended clear double the executing of living, and heresy is not stayed in the kidney invigorating, not eliminating evil just the wound, and synergism is played liver and kidney tonifying altogether, the effect of clearing away heat-damp and promoting diuresis eliminating stagnation.
Claims (7)
1. pharmaceutical composition for the treatment of benign prostate hyperplasia, it is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
Herba Epimedii 15-45 part, Carapax Trionycis 15-45 part, Radix Scutellariae 5-15 part, Herba Plantaginis 7.5-22.5 part.
2. pharmaceutical composition according to claim 1 is characterized in that: it is the medicament that is prepared from by following raw materials by weight proportions:
30 parts of Herba Epimedii, 30 parts of Carapax Trionycis, 10 parts of Radix Scutellariaes, 15 parts of Herba Plantaginiss.
3. pharmaceutical composition according to claim 1 and 2, it is characterized in that: it is to be active component by water of Herba Epimedii, Carapax Trionycis, Radix Scutellariae, Herba Plantaginis or extractive with organic solvent, adds acceptable accessories or complementary composition and is prepared into medicament pharmaceutically commonly used.
4. pharmaceutical composition according to claim 3 is characterized in that: described medicament is tablet, capsule, pill, granule, oral liquid.
5. method for preparing any described pharmaceutical composition of claim 1-4, it comprises the steps:
A, get raw material: Herba Epimedii, Carapax Trionycis, Radix Scutellariae, Herba Plantaginis;
B, get Herba Epimedii, Radix Scutellariae, Herba Plantaginis; Add the 70-80% alcoholic solution, decoct and extract, filter, filtrate concentrates;
C, get Carapax Trionycis, decoct with water, filter, filtrate concentrates;
D, the concentrated solution of b and c step is mixed, add acceptable accessories or complementary composition and be prepared into preparation pharmaceutically commonly used.
6. preparation method according to claim 6 is characterized in that: the described concentration of alcohol of b step is 70%.
7. the purposes of the described pharmaceutical composition of claim 1 in the medicine of preparation treatment benign prostate hyperplasia.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631388A (en) * | 2003-12-23 | 2005-06-29 | 王绍金 | Chinese traditional medicine for treating chronic prostatitis |
| CN101053624A (en) * | 2007-05-23 | 2007-10-17 | 李红 | Traditional Chinese medicinal for treating prostatic hyperplasia and chronic prostatitis and its preparation process |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631388A (en) * | 2003-12-23 | 2005-06-29 | 王绍金 | Chinese traditional medicine for treating chronic prostatitis |
| CN101053624A (en) * | 2007-05-23 | 2007-10-17 | 李红 | Traditional Chinese medicinal for treating prostatic hyperplasia and chronic prostatitis and its preparation process |
Non-Patent Citations (2)
| Title |
|---|
| > 20040630 董襄国等 良性前列腺增生辨证论治 358-359 1-7 第19卷, 第6期 2 * |
| > 20050630 金珊等 中西医结合治疗慢性前列腺炎的临床观察 81-82 1-7 第24卷, 第2期 2 * |
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