CN101590046A - The pharmaceutical composition that contains amlodipine and finasteride - Google Patents
The pharmaceutical composition that contains amlodipine and finasteride Download PDFInfo
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- CN101590046A CN101590046A CNA2008101130933A CN200810113093A CN101590046A CN 101590046 A CN101590046 A CN 101590046A CN A2008101130933 A CNA2008101130933 A CN A2008101130933A CN 200810113093 A CN200810113093 A CN 200810113093A CN 101590046 A CN101590046 A CN 101590046A
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Abstract
The invention discloses a kind of pharmaceutical composition that contains acceptable carrier on amlodipine, finasteride and the pharmaceutics, and the purposes of this pharmaceutical composition in preparation treatment prostatic hyperplasia relevant disease medicine.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 amlodipine and finasteride, and the pharmaceutical composition that contains amlodipine and finasteride is used for preventing, treating and delay the application of 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].Outgrowth body of gland causes posterior urethral stricture, crooked elongated, and the bladder bottom is raised, and causes urethral obstruction, takes place that dysuria, urination time prolong, occur that residual urine, bladder enlarge, girder forms, forms diverticulum again between girder.Further develop, vesicoureteral reflux can appear, renal function is affected, can merge calculus and urinary system infection, and then produce a series of symptoms: as frequent micturition, urgent micturition, nocturia increase, dysurea, dysuria, urinate hesitate, urinate that line attenuates, stuttering urination, last dribbling, urine retention sense, hematuria, urinary tract infection, vesical calculus, dysuria coexist with urinary incontinence and renal function goes down etc. eventually.Prostatic hyperplasia can have a strong impact on the life of elderly person quality.
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.
Amlodipine chemical name: 3-ethyl-5-methyl-2-(2-ammonia ethoxymethyl)-4-(2-chlorphenyl)-1,4-dihydro-6-methyl-3,5-pyridine dicarboxylate benzene sulfonate.L type calcium channel on the vasoactive smooth muscle cell film suppresses calcium ion and strides film intravasation smooth muscle, thereby reduces flow of calcium ions, and vascular smooth muscle tension force is descended, and is used for hypertension, anginal treatment.
Finasteride chemical name: N-(1, the 1-dimethyl ethyl)-3-oxygen-4-azepine-5 α-steroid-1-alkene-17 β-amide, be specificity II type 5 alpha reductase inhibitors, suppress the periphery testosterone and be converted into dihydrotestosterone, reduce dihydrotestosterone level in the tissues such as blood and prostate, skin.Prostatic growth promoter and hyperplasia of prostate depend on dihydrotestosterone, and finasteride suppresses prostatic hyperplasia by reducing dihydrotestosterone level in blood and the prostata tissue, improves the relevant clinical symptom of benign prostatic hyperplasia.
In patent and scientific and technical literature, we do not have to find to unite the scientific research document of amlodipine and finasteride treatment benign prostatic hyperplasia relevant disease in clinical and preclinical study.
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 amlodipine, finasteride and the pharmaceutics.
In pharmaceutical composition provided by the invention, amlodipine is as a kind of active component, becomes content of the present invention with acceptable carrier mutual group on finasteride and the pharmaceutics.Amlodipine can exist with the form of chemical compound, also can the medicinal precursor of amlodipine, forms such as amlodipine active metabolite or amlodipine salt exist.The preferred Amlodipine Besylate Tablet of the salt of amlodipine.As the equivalents of amlodipine, above-mentioned substance is also in the scope of protection of present invention.
In pharmaceutical composition provided by the invention, amlodipine content is 1～20mg, and preferred 2.5mg～10mg is more preferably 5mg～10mg.The content and the amlodipine content of the medicinal precursor of amlodipine, amlodipine active metabolite or amlodipine salt can be equal to replacement.
In pharmaceutical composition provided by the invention, finasteride becomes content of the present invention to create as a kind of active component with amlodipine with acceptable carrier mutual group on the pharmaceutics.Wherein, finasteride content is 1～20mg, and preferred 5～10mg is more preferably 5mg.
A preferred composition provided by the invention, the content of amlodipine is 5mg, finasteride content is 5mg.
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.
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 finasteride and amlodipine is made tablet, capsule or granule.
Find through a large amount of experiments, the pharmaceutical composition that amlodipine and finasteride are formed has unexpected effect to treatment benign prostatic hyperplasia relevant disease, therefore, the invention provides the pharmaceutical composition that contains acceptable carrier on amlodipine, finasteride 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, amlodipine is as a kind of active component, becomes content of the present invention with acceptable carrier mutual group on finasteride and the pharmaceutics.Amlodipine can exist with the form of chemical compound, also can the medicinal precursor of amlodipine, forms such as amlodipine active metabolite or amlodipine salt exist.The preferred amlodipine benzenesulphonate of the salt of amlodipine.As the equivalents of amlodipine, above-mentioned substance is also in the scope of protection of present invention.
In such use provided by the invention, amlodipine content is 1～20mg, and preferred 2.5mg～10mg is more preferably 5mg～10mg.The content and the amlodipine content of the medicinal precursor of amlodipine, amlodipine active metabolite or amlodipine salt can be equal to replacement.
In such use provided by the invention, finasteride becomes content of the present invention to create as a kind of active component with amlodipine with acceptable carrier mutual group on the pharmaceutics.Wherein, finasteride content is 1～20mg, and preferred 5～10mg is more preferably 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 it improves the effect of improvement respectively that the effect of optimum prostatitis property hypertrophy symptom significantly is better than two single medications.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 the compound amlodipine finasteride tablet of 2.5mg amlodipine and 1mg finasteride
Prescription: amlodipine 25g
Finasteride 1g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1g
Preparation method: will contain the 2.5g amlodipine and (use Amlodipine Besylate Tablet, available from pfizer inc (DaLian, China), its consumption is converted into the amount of the Amlodipine Besylate Tablet that contains the 25g amlodipine according to the molecular weight of the molecular weight of Amlodipine Besylate Tablet and amlodipine), the 1g finasteride (uses finasteride, available from the azure medical company limited in Zhuhai), the 50g lactose, 50g Celluloasun Microcrystallisatum and 10g starch are pulverized the back uniform mixing, make soft material with 10% polyvidone alcoholic solution, granulate, dry, granulate, with water content is about 3% granule and magnesium stearate mix homogeneously, with the tablet machine compacting in flakes.Every contains amlodipine 2.5mg, finasteride 1mg in 1000 compound tablet making, and its mass ratio is 2.5: 1.
Embodiment 2Preparation contains the compound amlodipine finasteride capsule of 2.5mg amlodipine and 2.5mg finasteride.
Prescription: amlodipine 2.5g
Finasteride 2.5g
Lactose 100～200g
Carboxymethyl starch sodium 15～25g
10% polyvidone alcoholic solution is an amount of
Magnesium stearate 1%
Preparation method: supplementary material was pulverized 80 mesh sieves, drying for standby.Get the Amlodipine Besylate Tablet that is equivalent to 2.5g amlodipine amount, finasteride 2.5g is 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 2.5mg amlodipine and 2.5mg finasteride in the compound capsule of making.
Embodiment 3Preparation contains the compound amlodipine finasteride granule of 2.5mg amlodipine and 5mg finasteride
Prescription: amlodipine 2.5g
Finasteride 5g
Lactose 850～950g
Carboxymethyl starch sodium 10～20g
Arabic gum 2g
10% polyvidone alcoholic 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 the Amlodipine Besylate Tablet that is equivalent to 2.5g amlodipine amount, finasteride 5g 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 amlodipine 2.5mg and finasteride 5mg in the compound granular agent of making.
Embodiment 4Preparation contains the compound amlodipine finasteride tablet of 2.5mg amlodipine and 10mg finasteride
Prescription: amlodipine 2.5g
Finasteride 10g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 2.5mg, finasteride 10mg in 1000 compound tablet making, and its mass ratio is 1: 4.
Embodiment 5Preparation contains the compound amlodipine finasteride tablet of 5mg amlodipine and 1mg finasteride
Prescription: amlodipine 5g
Finasteride 1g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 5mg, finasteride 1mg in 1000 compound tablet making, and its mass ratio is 5: 1.
Embodiment 6Preparation contains the compound amlodipine finasteride tablet of 5mg amlodipine and 2.5mg finasteride
Prescription: amlodipine 5g
Finasteride 2.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 5mg, finasteride 2.5mg in 1000 compound tablet making, and its mass ratio is 2: 1.
Embodiment 7Preparation contains the compound amlodipine finasteride tablet of 5mg amlodipine and 5mg finasteride
Prescription: amlodipine 5g
Finasteride 5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 5mg, finasteride 5mg in 1000 compound tablet making, and its mass ratio is 1: 1.
Embodiment 8Preparation contains the compound amlodipine finasteride tablet of 5mg amlodipine and 10mg finasteride
Prescription: amlodipine 5g
Finasteride 10g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 5mg, finasteride 10mg in 1000 compound tablet making, and its mass ratio is 1: 2.
Embodiment 9Preparation contains the compound amlodipine finasteride tablet of 10mg amlodipine and 1mg finasteride
Prescription: amlodipine 10g
Finasteride 1g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 10mg, finasteride 1mg in 1000 compound tablet making, and its mass ratio is 10: 1.
Embodiment 10Preparation contains the compound amlodipine finasteride tablet of 10mg amlodipine and 2.5mg finasteride
Prescription: amlodipine 10g
Finasteride 2.5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 10mg, finasteride 2.5mg in 1000 compound tablet making, and its mass ratio is 4: 1.
Embodiment 11Preparation contains the compound amlodipine finasteride tablet of 10mg amlodipine and 5mg finasteride
Prescription: amlodipine 10g
Finasteride 5g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 10mg, finasteride 5mg in 1000 compound tablet making, and its mass ratio is 2: 1.
Embodiment 12Preparation contains the compound amlodipine finasteride tablet of 10mg amlodipine and 10mg finasteride
Prescription: amlodipine 10g
Finasteride 10g
Lactose 50g
Microcrystalline Cellulose 50g
Starch 10g
Magnesium stearate 1g
Preparation method is identical with embodiment 1.Every contains amlodipine 10mg, finasteride 10mg in 1000 compound tablet making, and its mass ratio is 1: 1.
Embodiment 13The compound amlodipine finasteride is to the effect of BPH rat model
Animal and grouping SPF level male SD rat are divided into 5 groups, promptly blank (sham operated rats), model group, amlodipine group (0.5mg/kg), finasteride group (0.5mg/kg), the amlodipine+finasteride group (0.5mg/kg+0.5mg/kg) organized.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, amlodipine group, finasteride 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 amlodipine list is used does not have obvious influence to the prostate weight in wet base; The finasteride list is with can significantly reducing prostate volume and prostate index.The combination of amlodipine finasteride can significantly reduce prostate volume and prostate index, and more remarkable than two single medicine group effects, and the result has significant difference.See Table 1.
Table 1 amlodipine finasteride 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＜0.01 with the amlodipine group;
Compare ， $P＜0.05 with the finasteride group
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, amlodipine group, finasteride group rat urine time shorten significant prolongation blanking time of urinating; Amlodipine+finasteride group rat urine time significantly shortens, and has further than the amlodipine group and significantly improves, and significant difference is arranged.Amlodipine+finasteride group rat urine significant prolongation blanking time has significant significant difference than two single medicine group exercising results.See Table 2.
Table 2 amlodipine finasteride 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 amlodipine group;
Compare ， $P＜0.05 with the finasteride group
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, amlodipine group rat urine point is pressed and the voltage crest value of urinating all significantly reduces; The finasteride group is urinated, and a pressure is remarkable to be reduced.Compare with amlodipine group, finasteride group, amlodipine+finasteride group rat urine point is pressed and the voltage crest value of urinating further significantly reduces, and the result has significant significant difference.
Compare with the blank group, model group rat single voided volume significantly reduces; Compare with model group, finasteride group rat single voided volume significantly increases (P＜0.05); Amlodipine group rat single voided volume does not significantly increase (P＞0.05).Amlodipine+finasteride group rat single voided volume significantly increases (P＜0.01).Compare with amlodipine group, finasteride group, amlodipine+finasteride group rat single voided volume further significantly increases, and the result has remarkable significant difference.See Table 3.
Table 3 amlodipine finasteride 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 amlodipine group; Compare ， $P＜0.05 with the finasteride group
In the every index of embodiment 13 urodynamicss, prostate volume reduces after the administration of BPH rat, the exponential reduction of prostate, 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 amlodipine, list can significantly reduce the prostate index with finasteride, and the combination of amlodipine finasteride can be than the more remarkable reduction of two single medicine groups BPH rat prostate index.Amlodipine, finasteride list are used all has clear and definite improvement effect to the BPH rat urine point pressure and the voltage crest value of urinating, the finasteride list is used BPH rat urine point is pressed with clear and definite improvement effect, amlodipine finasteride combination demonstrates than the more significant improvement effect of single medicine group, point out the combination of two medicines to BPH cause block symptom and irritation all can further improve comprehensively.
Simultaneously, the combination of amlodipine finasteride can significantly be shortened the BPH rat urine time, and significant prolongation is urinated blanking time.Compare with amlodipine or finasteride with single, the combination of amlodipine finasteride has further improvement significantly to act on to each index, the prolongation of significance is particularly all arranged than amlodipine, finasteride list medicine group on index blanking time of urinating, also further reacted amlodipine finasteride combination and not only blocked aspect the symptom, and demonstrated tangible effect characteristics aspect the bladder excessive activities irritation improving in improvement.Simultaneously, the combination of amlodipine finasteride is compared with amlodipine or finasteride with single, and it is more remarkable to increase the effect of BPH rat single voided volume.
In sum, the combination of amlodipine finasteride is compared with amlodipine or finasteride list medicine group, 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 (10)
1. a pharmaceutical composition contains acceptable carrier on amlodipine, finasteride and the pharmaceutics.
2. according to the pharmaceutical composition described in the claim 1, it is characterized in that: described amlodipine content is 1～10mg, preferred 5～10mg.
3. according to the pharmaceutical composition described in the claim 1, it is characterized in that: described finasteride content is 1～20mg, preferred 5～10mg.
4. according to the pharmaceutical composition described in claim 2 or 3, it is characterized in that: described finasteride content is 5mg, and described amlodipine content is 5mg.
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 amlodipine, finasteride 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 amlodipine content is 1～10mg.
9. purposes according to claim 6 is characterized in that: described finasteride content is 1～20mg.
10. according to Claim 8 or the purposes described in 9, it is characterized in that: described finasteride content is 5mg, and described amlodipine content is 5mg.
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Application publication date: 20091202 |