CN101590059A - The pharmaceutical composition that contains naftopidil and dutasteride - Google Patents
The pharmaceutical composition that contains naftopidil and dutasteride Download PDFInfo
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- CN101590059A CN101590059A CNA2008101130948A CN200810113094A CN101590059A CN 101590059 A CN101590059 A CN 101590059A CN A2008101130948 A CNA2008101130948 A CN A2008101130948A CN 200810113094 A CN200810113094 A CN 200810113094A CN 101590059 A CN101590059 A CN 101590059A
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Abstract
The invention discloses a kind of purposes of pharmaceutical composition, promptly contain the purposes of compositions in preparation treatment prostatic hyperplasia relevant disease medicine of acceptable carrier on the dutasteride of naftopidil, pharmaceutical dosage of pharmaceutical dosage and the pharmaceutics.By enforcement of the present invention, the pharmaceutical composition that offers this special-purpose of patient is determined curative effect not only, but also can improve patient's compliance, and the patient is taken medicine conveniently, reduces medical expense, has better market prospect.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that contains naftopidil and dutasteride, and this pharmaceutical composition is used for the treatment of application in the medicine of benign prostatic hyperplasia relevant disease in preparation.The invention belongs to pharmaceutical field.
Background technology
(benign prostate hyperplasia BPH) is one of modal disease of elderly men to benign prostate hyperplasia.No.1 Hospital Affiliated to Beijing Medical Univ. after death performed an autopsy on sb to the prostatosis patient more than 40 years old in 1989, found that histology BPH sickness rate rises to 30.5% from 6.6% of Concord Hospital's report in 1936.BPH become one of commonly encountered diseases of clinical Urology Surgery [Gu Fangliu etc. benign prostatic hyperplasia and carcinoma of prostate are in the research of Chinese incidence. Chinese tumor .1997,6 (10): 19].Prostatic hyperplasia can have a strong impact on the life of elderly person quality.Outgrowth body of gland causes posterior urethral stricture, crooked elongated, the bladder bottom is raised, cause urethral obstruction, take place that dysuria, urination time prolong, residual urine occurs, bladder enlarges, and then produce a series of symptoms: as frequent micturition, urgent micturition, nocturia increase, dysurea, dysuria, urinate hesitate, urinate that line attenuates, stuttering urination, whole art dribbling, urine retention sense, hematuria, urinary tract infection, vesical calculus, dysuria and urinary incontinence coexists and renal function goes down etc.The urinary tract obstruction that BPH the causes phase symptom reason of urinating at first is the static factor of mechanicalness of hypertrophy body of gland compressing urethra.Simultaneously, prostate and bladder neck have abundant alpha-2-adrenoceptor, cause the tension force of prostate, capsula prostatica, bladder neck to increase when alpha-2-adrenoceptor is overexcited, increased the weight of the symptom of urethral obstruction, for producing the dynamic property factor of prostatic hyperplasia series symptom.
Lower urinary tract syndrome (lower urinary tract syndrome, LUTS) for storing up the general designation of the urine phase (zest) and/or (obstructive) symptom of urinating the phase, be the common symptom of gerontal patient [suggestion is recommended by the 5th international scientific committee of international benign prostatic hyperplasia Advisory Board: the assessment of elderly men lower urinary tract symptom and treatment. Chinese magazine of urology surgery .2001,22:564-570]: storage urine phase symptom (also claiming irritation in the past) comprises urgent micturition, frequent micturition, urinary incontinence, symptoms such as nocturia increases, the phase symptom of urinating mainly comprises dysuria, the urine line is thin, the urine back sound of rain pattering, urinary hesitancies etc. are based on dysuria.LUTS has higher incidence in the crowd: 5% child has enuresis nocturna, and 15% women and 7% male adult suffer from the urinary continence disorder disease; In the elderly men more than 70 years old, about 80% people suffers from benign prostatic hyperplasia, and prostate volumes wherein more than half approximately obviously increase, and wherein 50% prostate that increases can cause bladder outlet obstruction (BOO).LUTS can be caused that BPH is that the male patient brings out the topmost factor of LUTS by multiple factor.
Naftopidil chemical name: (±)-1-[4-(2-anisyl) piperazinyl]-3-(1-naphthoxy)-2-propanol, has blocking-up α 1 receptor acting, alleviate prostate due to this receptor excitement and urethra the sympathetic nerve sexual tension, to reduce urethra intrinsic pressure, improves the symptoms such as dysuria due to the benign prostate hyperplasia.
Dutasteride's chemical name: (5 α, 17 β)-N-[2, two (trifluoromethyl) phenyl of 5-]-the assorted male amine of 3-O-4-N--1-alkene-17-carboxylic acid amides, be specificity I, II type 5 alpha reductase inhibitors, prostatic growth promoter and hyperplasia of prostate depend on dihydrotestosterone, thereby the dutasteride suppresses the effect that 5 alpha-reductases are converted into testosterone dihydrotestosterone by forming stable complex with 5 alpha-reductases, reduce the dihydrotestosterone level in blood and the prostata tissue and suppress prostatic hyperplasia, improve the relevant clinical symptom of benign prostatic hyperplasia.
In patent and scientific and technical literature, we do not have to find that in clinical and preclinical study associating naftopidil and dutasteride treat the scientific research document of benign prostatic hyperplasia relevant disease.
Summary of the invention
The object of the present invention is to provide a kind of prevention, treat and delay the pharmaceutical composition of benign prostatic hyperplasia relevant disease, comprising: acceptable carrier on naftopidil, dutasteride and the pharmaceutics.
In pharmaceutical composition provided by the invention, naftopidil becomes content of the present invention to create as a kind of active component with the dutasteride with acceptable carrier mutual group on the pharmaceutics.Naftopidil can exist with the form of chemical compound, also can the medicinal precursor of naftopidil, forms such as naftopidil active metabolite or naftopidil salt exist.As the equivalents of naftopidil, above-mentioned substance is also in the scope of protection of present invention.
In pharmaceutical composition provided by the invention, naftopidil content is 12.5mg～100mg, preferred 25mg～50mg.The content and the naftopidil content of the medicinal precursor of naftopidil, naftopidil active metabolite, naftopidil salt or naftopidil esters can be equal to replacement, preferred hydrochloric acid naftopidil.In pharmaceutical composition provided by the invention, the dutasteride becomes content of the present invention to create as a kind of active component with naftopidil with acceptable carrier mutual group on the pharmaceutics.
In pharmaceutical composition provided by the invention, dutasteride's content is 0.5～10mg, preferred 2.5～5mg
At a preferred composition provided by the invention, the content of naftopidil is 25mg, and dutasteride's content is 2.5mg.
The dosage form of this pharmaceutical composition includes but not limited to conventional tablet, bilayer tablet, multilayer tablet, slow releasing tablet, the single chamber controlled release tablet, two chambers controlled release tablet, the pore type controlled release tablet, sublingual lozenge, oral cavity quick disintegrating slice, dispersible tablet, enteric coatel tablets, granule, pill, enteric coated capsule, delayed-release tablet, regularly/the position releasing piece, conventional capsule, slow releasing capsule, controlled release capsule, the capsule that contains micropill or small pieces, the pH dependent form capsule that contains micropill or small pieces, granule, oral liquid, dosage form such as membrane or patch, what should particularly point out is that the pharmaceutical composition that will contain naftopidil and dutasteride is made tablet, capsule or granule.
Also contain the pharmaceutics acceptable carrier in this pharmaceutical composition, can be made into oral formulations, comprise tablet, capsule, granule etc., described pharmaceutically acceptable carrier includes excipient and the accessory drugs that helps reactive compound is mixed with pharmaceutical formulation when making tablet, compositions as one or more materials of starch, microcrystalline Cellulose, inorganic salts, sucrose, dextrin, lactose, Icing Sugar, glucose, sodium chloride, cysteine, citric acid and sodium sulfite etc. belongs to this area general knowledge.
Find through a large amount of experiments, the pharmaceutical composition that naftopidil and dutasteride form has unexpected effect to treatment benign prostatic hyperplasia relevant disease, therefore, the invention provides the pharmaceutical composition that contains acceptable carrier on naftopidil, dutasteride and the pharmaceutics is used for preventing, treating and delay the medicine of benign prostatic hyperplasia relevant disease in preparation purposes.
In the present invention, the prostatic hyperplasia relevant disease comprises lower urinary tract syndrome, the lower urinary tract syndrome that prostatic hyperplasia, prostatic hyperplasia occur together.Prostatic hyperplasia and lower urinary tract syndrome connect each other on symptom, and the lower urinary tract syndrome that prostatic hyperplasia occurs together is complex interactions causes between prostate and bladder excitation, blocks symptom.The lower urinary tract syndrome that prostatic hyperplasia, prostatic hyperplasia occur together, lower urinary tract syndrome are complementary three diseases, are referred to as the prostatic hyperplasia relevant disease.
In such use provided by the invention, naftopidil becomes content of the present invention to create as a kind of active component with the dutasteride with acceptable carrier mutual group on the pharmaceutics.Naftopidil can exist with the form of chemical compound, also can the medicinal precursor of naftopidil, naftopidil active metabolite or forms such as naftopidil salt, esters exist.The preferred hydrochloric acid naftopidil of the salt of naftopidil.As the equivalents of naftopidil, above-mentioned substance is also in the scope of protection of present invention.
In such use provided by the invention, naftopidil content is 12.5mg～100mg, preferred 25mg～50mg.The content and the naftopidil content of the medicinal precursor of naftopidil, naftopidil active metabolite or naftopidil salt can be equal to replacement.
In such use provided by the invention, the dutasteride becomes content of the present invention to create as a kind of active component with naftopidil with acceptable carrier mutual group on the pharmaceutics.Dutasteride's content is 0.5～10mg, preferred 0.5～5mg.
The invention has the beneficial effects as follows: pharmaceutical composition provided by the invention has obvious synergism, its synergism is the collaborative optimum prostatitis property hypertrophy symptom effect that improves, and its action effect that improves optimum prostatitis property hypertrophy symptom significantly is better than the action effect that improves that two prescriptions use.By enforcement of the present invention, the pharmaceutical composition that offers this special-purpose of patient can improve patient's compliance, and the patient is taken medicine conveniently, reduces medical expense, has better market prospect.
The specific embodiment
Embodiment 1Preparation contains 25mg naftopidil and 0.5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 25g
Dutasteride 0.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method: will contain 25g naftopidil, 1g dutasteride, 50g lactose, 50g microcrystalline Cellulose and 10g starch and pulverize the back uniform mixing, make soft material with 10% polyvidone alcoholic solution, granulation, dry, granulate, with water content is about 3% granule and magnesium stearate mix homogeneously, with the tablet machine compacting in flakes.Every contains naftopidil 25mg, dutasteride 0.5mg in 1000 compound tablet making, and its mass ratio is 50: 1.
Embodiment 2Preparation contains 25mg naftopidil and 1mg dutasteride's compound recipe naftopidil dutasteride capsule
Prescription: naftopidil 25g
Dutasteride 1g
Lactose 100～200g
Carboxymethyl starch sodium 15～25g
10% polyvidone aqueous solution is an amount of
Magnesium stearate 1%
Preparation method: supplementary material was pulverized 80 mesh sieves, drying for standby.Get and be equivalent to 25g naftopidil, 1g dutasteride according to equivalent incremental method mix homogeneously, add 100～200g lactose, 15～25g carboxymethyl starch sodium (the definite consumption of adjuvant is adjusted according to the active medicine consumption), according to equivalent incremental method uniform mixing, make soft material with 10% polyvidone alcoholic solution, 20 mesh sieves are granulated, 60 ℃ of dry about 2h, 20 mesh sieve granulate, controlling particulate water content is 2-3%, with dried granule and recipe quantity magnesium stearate mix homogeneously, semi-finished product detect, and measure content, the Capsules of packing into promptly gets 1000 capsules.Note lucifuge in the preparation process.The qualified back of product inspection aluminium-plastic bubble plate packing keeps in Dark Place.Every contains 25mg naftopidil and 1mg dutasteride in the compound capsule of making.
Embodiment 3Preparation contains 25mg naftopidil and 2.5mg dutasteride's compound recipe naftopidil dutasteride granule
Prescription: naftopidil 25g
Dutasteride 2.5g
Lactose 850～950g
Carboxymethyl starch sodium 10～20g
Arabic gum 2g
10% polyvidone aqueous solution is an amount of
Orange flavor 2g
Aspartame 5g
Polyethylene Glycol 1%
Preparation method: supplementary material was pulverized 80 mesh sieves, drying for standby.Get and be equivalent to the 25g naftopidil, 2.5g the dutasteride is according to equivalent incremental method mix homogeneously, add 850～950g lactose, 10～20g carboxymethyl starch sodium (the definite consumption of adjuvant is adjusted according to the active medicine consumption), according to equivalent incremental method uniform mixing, make soft material with 10% polyvidone alcoholic solution, 18 mesh sieves are granulated, 60 ℃ of dry about 2h, 16 mesh sieve granulate, controlling particulate water content is below 2%, with dried granule and recipe quantity orange flavor, aspartame, the magnesium stearate mix homogeneously, semi-finished product detect, and measure content, and the aluminum bag of packing into promptly gets 1000 bags.Note lucifuge in the preparation process.Every bag contains 25mg naftopidil and 2.5mg dutasteride in the compound granular agent of making.
Embodiment 4Preparation contains 25mg naftopidil and 5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 25g
Dutasteride 5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 25mg, dutasteride 5mg in 1000 compound tablet making, and its mass ratio is 5: 1.
Embodiment 5Preparation contains 50mg naftopidil and 0.5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 50g
Dutasteride 0.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 50mg, dutasteride 0.5mg in 1000 compound tablet making, and its mass ratio is 100: 1.
Embodiment 6Preparation contains 50mg naftopidil and 1mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 50g
Dutasteride 1g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 50mg, dutasteride 1mg in 1000 compound tablet making, and its mass ratio is 50: 1.
Embodiment 7Preparation contains 50mg naftopidil and 2.5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 50g
Dutasteride 2.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 50mg, dutasteride 2.5mg in 1000 compound tablet making, and its mass ratio is 20: 1.
Embodiment 8Preparation contains 50mg naftopidil and 5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 50g
Dutasteride 5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 50mg, dutasteride 5mg in 1000 compound tablet making, and its mass ratio is 10: 1.
Embodiment 9Preparation contains 75mg naftopidil and 0.5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 75g
Dutasteride 0.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 75mg, dutasteride 0.5mg in 1000 compound tablet making, and its mass ratio is 150: 1.
Embodiment 10Preparation contains 75mg naftopidil and 1mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 75g
Dutasteride 1g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 75mg, dutasteride 1mg in 1000 compound tablet making, and its mass ratio is 75: 1.
Embodiment 11Preparation contains 75mg naftopidil and 2.5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 75g
Dutasteride 2.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 75mg, dutasteride 2.5mg in 1000 compound tablet making, and its mass ratio is 30: 1.
Embodiment 12Preparation contains 75mg naftopidil and 5mg dutasteride's compound recipe naftopidil dutasteride sheet
Prescription: naftopidil 75g
Dutasteride 5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains naftopidil 75mg, dutasteride 5mg in 1000 compound tablet making, and its mass ratio is 15: 1.
Embodiment 13Compound recipe naftopidil dutasteride is to the effect of BPH rat model
Animal and grouping SPF level male SD rat are divided into 5 groups, promptly blank organize (sham operated rats), and model group, naftopidil group (2.5mg/kg), the dutasteride organizes (0.5mg/kg), and naftopidil+dutasteride organizes (2.5mg/kg+0.5mg/kg).By operation or the index determining progress of 5 rats every day, totally 5 groups of rats are divided into 20 batches of sequential carrying out.
After modelling and administration model group, naftopidil group, dutasteride's group, the compound recipe group rats by intraperitoneal injection 3.5% chloral hydrate 350mg/kg anesthesia, aseptic condition is extractd bilateral testes (castration) down, intramuscular injection penicillin 20,000 U/kg, for three days on end, castration is performed the operation and is only begun testosterone propionate 0.5mg/ that subcutaneous injection is dissolved in olive oil after 1 week, every day 1 time, continuous 8 weeks.In the time of each administration group subcutaneous injection testosterone propionate, press 1ml100g
-1The body weight gastric infusion, every day 1 time, continuous 8 weeks; Blank group and model group are irritated appearance normal saline such as stomach respectively.
Intrinsic pressure and the urine quantity measuring method of rat bladder is respectively organized 1.5 hours pneumoretroperitoneums of rat last administration and is injected 20% urethane (1gkg
-1) anesthesia, vertically cut on pubic arch top, expose bladder, at duck eye of bladder top thorn, insert the internal and external casing conduit, a conduit (trocar sheath, diameter 1.2mm) lead the physiology recording system by pressure receptor with PC-Lab links to each other more, another root conduit (inner sleeve, diameter 0.61mm) links to each other with the constant speed syringe pump and constant speed is paid close attention to normal saline, and rate of flooding is 2mlh
-1Each rat is write down indexs such as each urodynamics parameter and single voided volume respectively after in stable condition 0.5 hour.
Rat prostate assessment of indices rat is won its prostate veutro leaf, coagulation gland and dorsal part leaf respectively, and takes by weighing weight in wet base after measuring and finishing, and calculates the prostate index after the merging full weight as follows: prostate index=prostate weight in wet base (mg)/body weight (g)
The data statistics data represent that with Mean ± SD each is organized and relatively adopts variance analysis between each index.
Experimental result
To BPH rat model body weight, prostate weight in wet base and prostate is exponential influence modeling after, each organizes the rat body weight no significant difference.The model group rat is compared with blank group, and prostate weight in wet base and prostate index all significantly raise, and shows BPH model modeling success.The naftopidil list is used does not have obvious influence to the prostate weight in wet base; The dutasteride is single with can significantly reducing prostate volume and prostate index.Naftopidil dutasteride combination can significantly reduce prostate volume and prostate index, and more remarkable than two single medicine group effects, and the result has significant difference.The results are shown in Table 1.
Table 1 naftopidil dutasteride compositions is to the influence of BPH rat model body weight, prostate weight in wet base and prostate index (PI) (x ± s)
Compare * P＜0.05, * * P＜0.01 with model group; Compare #P＜0.05 with the naftopidil group;
Organize comparison ， $P＜0.05 ， $$P＜0.01 with the dutasteride
2. BPH rat model urination time, the influence of the blanking time of urinating are compared with blank group, model group rat urine time significant prolongation, significantly shorten the blanking time of urinating.Compare with model group, the naftopidil group rat urine time significantly shortens, significant prolongation blanking time of urinating; The dutasteride organizes the rat urine time has certain shortening, significant prolongation blanking time of urinating.Naftopidil+dutasteride organizes the rat urine time and significantly shortens, and has further than dutasteride's group and significantly improves, and naftopidil+dutasteride organizes rat urine significant prolongation blanking time, has significant significant difference than two single medicine group exercising results.See Table 2.
Table 2 naftopidil dutasteride compositions is to BPH rat urine time and the influence of urinating blanking time (x ± s)
Compare * P＜0.05, * * P＜0.01 with model group; Compare #P＜0.05 with the naftopidil group;
Organize comparison ， $P＜0.05 ， $$P＜0.01 with the dutasteride
To BPH rat urine point press, the voltage crest of urinating value and single voided volume influence model group and blank group rat relatively, urinate and press and the voltage crest value of urinating all significantly raises.Compare with model group, naftopidil group and dutasteride organize rat urine point and press significantly reduction, and the voltage crest of urinating value has certain reduction.Organize comparison with naftopidil group, dutasteride, naftopidil+dutasteride organizes rat urine point pressure and the voltage crest value of urinating further significantly reduces, and the result has significant significant difference.
Compare with model group, the dutasteride organizes rat single voided volume significantly increases (P＜0.05); The increase of naftopidil group rat single voided volume is remarkable (P＞0.05) not.Naftopidil+dutasteride organizes rat single voided volume significantly increases (P＜0.01).Compare with the naftopidil group, naftopidil+dutasteride organizes rat single voided volume further significantly to be increased, and the result has remarkable significant difference.See Table 3.
Table 3 naftopidil dutasteride compositions to BPH rat urine point press, the influence of the voltage crest of urinating value and single voided volume (x ± s)
Compare * P＜0.05, * * P＜0.01 with model group; Compare #P＜0.05 with the naftopidil group;
Organize comparison ， $P＜0.05 with the dutasteride
In the every index of embodiment 13 urodynamicss, prostate volume reduces after the administration of BPH rat, the prostate index decreased, urination time shortens, a pressure drop of urinating is low mainly to have reflected the improvement of medicine to bladder outlet obstruction (BOO) symptom (BOO) with the increase of single voided volume, the prolongation of urinating blanking time has mainly reflected the inhibition of medicine to being overexcited property of detrusor of bladder (OAB), the reduction of the voltage crest of urinating value has reflected the medicine improvement that block at the bladder outlet position when urinating on the one hand, has also reflected the inhibition to being overexcited property of body of bladder smooth muscle on the other hand.
This result of study shows: single not remarkable to the influence of BPH rat prostate index with naftopidil, list can significantly reduce the prostate index with the dutasteride, and naftopidil dutasteride combination can be than the more remarkable reduction of two single medicine groups BPH rat prostate index.This result of study shows: single do not have obviously influence with naftopidil to the prostate index, and single the combination all with dutasteride and naftopidil dutasteride can significantly be reduced BPH rat prostate index.Naftopidil, dutasteride singly use all has clear and definite improvement effect to BPH rat urine point pressure, BPH rat urine point is pressed for naftopidil dutasteride combination and the voltage crest value of urinating all demonstrates than the improvement effect significantly of single medicine group, point out two medicines make up to BPH cause block symptom and irritation all can further improve comprehensively.
Simultaneously, naftopidil dutasteride combination can significantly be shortened the BPH rat urine time, and significant prolongation is urinated blanking time.Compare with naftopidil or dutasteride with single, naftopidil dutasteride combination has further improvement significantly to act on to each index, particularly on the urination time index, significantly shorten than the single medicine group of dutasteride, the prolongation of significance is all arranged than naftopidil, the single medicine group of dutasteride on index blanking time of urinating, also further reacted naftopidil dutasteride combination and not only blocked aspect the symptom, and demonstrated tangible effect characteristics aspect the bladder excessive activities irritation improving in improvement.Simultaneously, naftopidil dutasteride combination is compared with naftopidil with single, and it is more remarkable to increase the effect of BPH rat single voided volume.
In sum, the single medicine group of naftopidil dutasteride combination and naftopidil or dutasteride is compared, and can control or improve blocking and the bladder excessive activities irritation that BPH causes further, fully and effectively, significantly is better than the action effect of single medicine.
Claims (9)
1. a pharmaceutical composition contains acceptable carrier on naftopidil, dutasteride and the pharmaceutics.
2. according to the pharmaceutical composition described in the claim 1, it is characterized in that: described naftopidil content is 12.5～100mg, preferred 25～50mg.
3. according to the pharmaceutical composition described in the claim 1, it is characterized in that: described dutasteride's content is 0.5～10mg, preferred 2.5～5mg.
4. according to claim 2 or 3 described pharmaceutical compositions, it is characterized in that: described dutasteride's content is 2.5mg, and the content of naftopidil is 25mg.
5. pharmaceutical composition according to claim 1 is characterized in that the pharmacy dosage form of described pharmaceutical composition is an oral formulations, comprises tablet, capsule or granule.
6. the pharmaceutical composition that contains acceptable carrier on naftopidil, dutasteride and the pharmaceutics is used for preventing, treating and delay the purposes of the medicine of benign prostatic hyperplasia relevant disease in preparation.
7. purposes according to claim 6 is characterized in that: described prostatic hyperplasia relevant disease comprises lower urinary tract syndrome, the lower urinary tract syndrome that prostatic hyperplasia, prostatic hyperplasia occur together.
8. purposes according to claim 6 is characterized in that: described naftopidil content is 12.5～100mg.
9. purposes according to claim 6 is characterized in that: described dutasteride's content is 0.5～10mg.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008101130948A CN101590059A (en) | 2008-05-27 | 2008-05-27 | The pharmaceutical composition that contains naftopidil and dutasteride |
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| CNA2008101130948A CN101590059A (en) | 2008-05-27 | 2008-05-27 | The pharmaceutical composition that contains naftopidil and dutasteride |
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