CN100372538C - Dispersible tablet of alfuzosin hydrochloride - Google Patents

Dispersible tablet of alfuzosin hydrochloride Download PDF

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Publication number
CN100372538C
CN100372538C CNB2004100907284A CN200410090728A CN100372538C CN 100372538 C CN100372538 C CN 100372538C CN B2004100907284 A CNB2004100907284 A CN B2004100907284A CN 200410090728 A CN200410090728 A CN 200410090728A CN 100372538 C CN100372538 C CN 100372538C
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alfuzosin
alfuzosin hydrochloride
dispersible tablet
hydrochloride
medicine
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CN1634066A (en
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赵志全
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Lunan Pharmaceutical Group Corp
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Lunan Pharmaceutical Group Corp
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Abstract

The present invention belongs to the medicine technology, especially a dispersible tablet dosage form of alfuzosin hydrochloride. Compared with the existing alfuzosin hydrochloride common tablets, the alfuzosin hydrochloride dispersible tablet in accordance with the present invention exhibits remarkably improved pharmaceutical absorption rate which accelerates the clinical curative effects; and the bioavailability is also improved greatly, this may be more obvious for aged patients with lowered gastrointestinal tract absorbing functions. The present invention conquers the technology prejudice in prior art that the common tablets of alfuzosin can achieve the objective of rapid respond symptomatically and it is not necessary to and there is no room to exploit quick-effective dosage forms, resolves the individuation problem that the medicine taking time and dosage dose are regulated according to symptoms when aged benign prostate gland hyperplasy patients take alfuzosin hydrochloride medicine, and not only rapidly alleviates patient symptoms, but also avoids serious adverse reactions such as orthostatic hypotension. The present invention is convenient for aged and children patients to take medicine, with stable formulation, fast absorption, high bioavailability and few adverse reaction.

Description

Dispersible tablet of alfuzosin hydrochloride
Technical field
The invention belongs to pharmaceutical preparations technology.
Background technology
Benign prostatic hyperplasia (Benign Prostatic Hyperplasia, BPH) be the elderly men commonly encountered diseases, be the most commonly encountered diseases that causes male's dysuria because of, sickness rate increased with the age, the person had 50% in 60 years old, the person then had old people's histological examination discovery prostatic hyperplasia of 88% in 80 years old, and wherein part can develop into the BPH of clinical symptoms.Prostatic hyperplasia can cause bladder neck obstruction, influences the normal function of urinary system, produces dysuria in various degree, finally causes bladder and nephropathy, causes renal function injury, and patient's quality of life is had a strong impact on.
Alfuzosin hydrochloride also is a quinazoline derivant, is selectivity α 1Receptor blocking agent has the following advantages:
1, to the α of urogenital tract 1-receptor-selective is strong
In the model, alfuzosin hydrochloride is compared with terazosin with prazosin, to urogenital tract α in animal body 1-receptor has more selectivity, to can obviously reducing urethral resistance under blood pressure and the heart rate function minimum doses.
2, rapid-action, clinical efficacy is lasting
Alfuzosin hydrochloride can improve urine flow rate and relief of symptoms fast.Qmax significantly improves in the single oral alfuzosin hydrochloride 2.5mg, 1.5h.Long term administration (≤30 months) can be kept curative effect, and curative effect is suitable with the alpha 1-receptor antagonist prazosin.
3, side effect is little
7.5~10mg/ days 30 months clinical trial of oral hydrochloride alfuzosin shows that the side effect incidence rate of alfuzosin hydrochloride is similar to placebo, and the side effect incidence rate relevant with vasodilation is lower than prazosin.
Have so good effect and very low untoward reaction though alfuzosin is used for the treatment of benign prostatic hyperplasia, can common tablet and slow releasing tablet only be arranged for the dosage form of clinical use.
Because the morbidity patient of benign prostatic hyperplasia mostly is the gerontal patient, and sickness rate increases with the increase at age, nearly all can find histology's evidence of prostatic hyperplasia greater than 80 years old elderly men, have a lot of old peoples' benign prostatic hyperplasia to show certain clinical symptoms.Thereby for a lot of gerontal patients, the oral tablet of alfuzosin may exist takes situation of difficult, and inconvenient patient takes.Ordinary tablet and slow releasing tablet that alfuzosin is arranged on the market now.Test shows to the pharmacokinetics of alfuzosin, is 64% to healthy volunteer's oral administration biaavailability, in clinical application reality, take the patient and be the old people, and the old people is along with the increase at age, and the gastrointestinal absorption function descends, and its bioavailability may be lower.Therefore, from a kind of new formulation that can improve gerontal patient's bioavailability of angle exploitation of pharmaceutics, be necessary.Developing the medicine of multiple good effect, rapid-action, taking convenience for vast Benign Prostatic Hypertrophy, is the objective of the struggle of pharmacy corporation, also meets the interests of extensive patients.
In addition, old people's gastrointestinal absorption function and hepatic and renal function individual variation are bigger, carry out the individuation of medication, to under the prerequisite of the drug effect of effectively bringing into play alfuzosin hydrochloride, the toxicity untoward reaction that causes because of blood drug level is too high that farthest reduces alfuzosin hydrochloride has great significance.But the individuation of medication is difficult to carry out with being difficult to popularize because of the loaded down with trivial details of determination of plasma concentration in clinical practice.Alfuzosin hydrochloride can produce serious postural hypotension under the too high situation of blood drug level, carry out the adjusting of dosage and administration time according to the situation of clinical symptoms and untoward reaction, a kind of effective and efficient manner of can yet be regarded as.
Alfuzosin hydrochloride obtained Germany and United States Patent (USP) in 1979, the patent No. is Ger.Pat.2, and 904,445 and U.S.Pat.4315,007.China was in import alfuzosin hydrochloride slow releasing tablet (5mg) in 2000, and commodity are called Sang Ta, and registration certificate number is X20000454.Lunan Pharmacy Co. Ltd's company limited obtained the New Drug Certificate of alfuzosin hydrochloride raw material and tablet (2.5mg) in 2003, authentication code is respectively: H20030065 and H20030066.Adult's common dose is one time 1 (2.5mg), and 3 times on the one, gerontal patient's initial dose morning and evening every day each 1 (2.5mg) increases to one at most 4 (10mg).
Summary of the invention
As previously mentioned, alfuzosin has rapid-action advantage, behind the conventional tablet 2.5mg of oral alfuzosin, can significantly improve the peak urinary flow rate rate in 1.5 hours, obviously improves prostatic hyperplasia patient's dysuria symptom.It is 3.19 ± 0.60h that the blood plasma of young healthy volunteer's single oral this product 5mg is eliminated the half-life.It is mainly through liver metabolism, only have 11% with the original shape medicament forms by renal excretion.Therefore prior art thinks that the conventional tablet of alfuzosin can reach the rapid purpose of improving symptom, do not develop the necessity and the leeway of quick-acting dosage forms, and its half-life is shorter relatively, and can prepare becomes slow releasing preparation and take number of times with minimizing.Thereby alfuzosin from succeed in developing over more than 20 year, have only minority dosage forms such as common tablet and slow releasing tablet to use clinically, the dosage form of dispersible tablet is not developed.
The present invention is according to the actual needs of old Benign Prostatic Hypertrophy drug usage individuation, overcome above-mentioned prior art prejudice, developed the dispersible tablet of alfuzosin, reached Benign Prostatic Hypertrophy curative effect purpose more rapidly, in addition, the present invention also has following advantage:
1. the common tablet of alfuzosin has side effect of digestive tract such as nauseating, stomachache and diarrhoea, tablet formulation of the present invention has further improved the principal agent dissolubility, promptly meet water and can form even viscosity suspension rapidly, can be dispersed into granule in the rapid disintegrate of gastrointestinal tract, the medicine distribution area is increased, absorption point increases, avoid ordinary preparation too high in the gastrointestinal tract local drug concentration, shortcomings such as stimulating gastrointestinal mucosa have reduced untoward reaction, have improved the compliance of patient's medication greatly.
2. to the patient of gerontal patient and dysphagia, can in water, disperse back and fruit juice, milk and clothes.
3. production technology of the present invention is simple, uses the conventional tablet production equipment and can produce.
4. the Production and Packaging cost of existing tablet is low, transports, stores advantage easily, has the taking convenience of liquid preparation again, the characteristics that bioavailability is high.Dispersion that the present invention is good and dissolving out capability have more practical significance to the gerontal patient that gastrointestinal function descends.
5. alfuzosin hydrochloride is in vivo mainly through liver metabolism, on a small quantity with the form of prototype through renal excretion, gerontal patient's hepatic and renal function descends, the half-life of alfuzosin is significant prolongation therefore, compare with the slow releasing tablet of alfuzosin, after dispersible tablet of alfuzosin of the present invention is regulated the medication number of times according to clinical symptoms, can not produce the body accumulation of alfuzosin, avoid the generation of serious adverse reactions such as postural hypotension.
Technical scheme
Alfuzosin hydrochloride dosage form of the present invention is a tablet formulation, and principal agent composition alfuzosin hydrochloride amount is optimized for 0.1~100mg, more is optimized for 1~50mg, and optimum turns to 2.5mg.
Disintegrating agent is the tablet formulation disintegrating agent commonly used of preparation tablet formulation, and the content of disintegrating agent is optimized for 1~80% among the present invention, more is optimized for 5~20%.
Through a large amount of experimentatioies, determined the final technology preparation of dispersible tablet of alfuzosin hydrochloride, and confirmed that in animal experiment the present invention really has above-mentioned advantage.In test, we have selected multiple medicinal disintegrating agent with disintegration properties to compare, and find that not all disintegrating agent that can be used for dispersible tablet can both be applied to the present invention.The technical barrier that the present invention solves, also be technical characterictic is the selection to disintegrating agent, finally selected disintegrating agent and be in the disintegrating agents such as starch, pregelatinized Starch, carboxymethyl starch sodium, hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, hydroxypropyl starch, carboxymethylcellulose calcium, sodium alginate, hydroxy acid cellulose, sodium carboxymethyl cellulose, methacrylic acid, divinylbenzene copolyesters, IRP-88, guar gum, Herba Xanthii glue, glucosan, carboxymethylcellulose calcium one or more.
In research process, investigated the preparation technology of dispersible tablet of alfuzosin hydrochloride, determined that its preparation technology is pharmaceutically useful auxiliary additive and the crospolyvinylpyrrolidone mix homogeneously that takes by weighing recipe quantity, then with the alfuzosin hydrochloride of recipe quantity and its by the equivalent method mixing that progressively increases, get a uniform mixing powder, granulate and dry back adding recipe quantity lubricant mixing tabletting or directly in above-mentioned mixed powder, add recipe quantity lubricant mixing tabletting, promptly.
Description of drawings:
Fig. 1: the external stripping curve of prescription A: Fig. 2: the external stripping curve of prescription B: Fig. 3: the external stripping curve of prescription C: Fig. 4: the external stripping curve of prescription D: Fig. 5: the external stripping curve of prescription E: Fig. 6: the external stripping curve of prescription F: Fig. 7: the external stripping curve of prescription G: Fig. 8: the external stripping curve of prescription H:
The specific embodiment
Embodiment (recipe quantity is 1000):
Eight kinds of concrete prescriptions:
Prescription A:
Alfuzosin hydrochloride 0.1g
Microcrystalline Cellulose (filler) 48g
Carboxymethyl starch sodium (disintegrating agent) 0.5g
Magnesium stearate (lubricant) 0.9g
Micropowder silica gel (fluidizer) 0.5g
Preparation technology: principal agent is crossed 120 mesh sieves, and filler, disintegrating agent are crossed 100 mesh sieves, takes by weighing filler, the disintegrating agent mix homogeneously of recipe quantity, then with the principal agent of recipe quantity and its by the equivalent method mixing that progressively increases, add the recipe quantity lubricant, mixing, tabletting are promptly.Dispersible tablet is limited to 3.0min when disperseing.
Prescription B:
Alfuzosin hydrochloride 1g
Microcrystalline Cellulose (filler) 80g
Hydroxypropyl cellulose (disintegrating agent) 3g
2%PVP K30Ethanol solution (binding agent) 30g
Magnesium stearate (lubricant) 0.8g
Preparation technology: principal agent is crossed 120 mesh sieves, and filler, disintegrating agent are crossed 100 mesh sieves, takes by weighing filler, the disintegrating agent mix homogeneously of recipe quantity, then with the principal agent of recipe quantity and its by the equivalent method mixing that progressively increases, add binding agent and granulate in right amount, dry back adds recipe quantity lubricant mixing, and tabletting promptly.Dispersible tablet is limited to 2.8min when disperseing.
Prescription C:
Alfuzosin hydrochloride 2.5g
Microcrystalline Cellulose (filler) 90g
Crospolyvinylpyrrolidone (disintegrating agent) 5g
5% starch slurry (binding agent) 40g
Magnesium stearate (lubricant) 0.5g
Preparation technology is with prescription B.Dispersible tablet is limited to 2.5min when disperseing.
Prescription D:
Alfuzosin hydrochloride 10g
Microcrystalline Cellulose (filler) 78g
Crospolyvinylpyrrolidone (disintegrating agent) 10g
2%PVP K30Aqueous solution (binding agent) 50g
Magnesium stearate (lubricant) 1g
Preparation technology: principal agent is crossed 120 mesh sieves, and filler, disintegrating agent are crossed 100 mesh sieves, takes by weighing principal agent, filler, the disintegrating agent mix homogeneously of recipe quantity, adds binding agent and granulates in right amount, and dry back adds recipe quantity lubricant mixing, and tabletting promptly.Dispersible tablet is limited to 2.0min when disperseing.
Prescription E:
Alfuzosin hydrochloride 30g
Lactose (filler) 48g
Carboxymethyl starch sodium (disintegrating agent) 20g
2%PVP K30Aqueous solution (binding agent) 50g
Magnesium stearate (lubricant) 1g
Preparation technology is with prescription D.Dispersible tablet is limited to 2.2min. when disperseing
Prescription F:
Alfuzosin hydrochloride 50g
Lactose (filler) 34g
Crospolyvinylpyrrolidone (disintegrating agent) 60g
5%PVP K30Ethanol solution (binding agent) 100g
Magnesium stearate (lubricant) 1g
Preparation technology is with prescription D.Dispersible tablet is limited to 1.0min when disperseing.
Prescription G:
Alfuzosin hydrochloride 70g
Microcrystalline Cellulose (disintegrating agent) 242g
Preparation technology: principal agent is crossed 120 mesh sieves, and disintegrating agent is crossed 100 mesh sieves, takes by weighing principal agent, the disintegrating agent mix homogeneously of recipe quantity, adds an amount of dehydrated alcohol amount and granulates, and dry back tabletting promptly.Dispersible tablet is limited to 0.7min when disperseing.
Prescription H:
Alfuzosin hydrochloride 100g
Crospolyvinylpyrrolidone (disintegrating agent) 560g
6%PVP K30Aqueous solution (binding agent) 500g
Magnesium stearate (lubricant) 6g
Micropowder silica gel (fluidizer) 4g
Preparation technology is with prescription D.Dispersible tablet is limited to 0.1min when disperseing.
Dispersible tablet of alfuzosin hydrochloride dispersing uniformity and dissolution in vitro inspection
1, the dispersible tablet of alfuzosin hydrochloride dispersing uniformity is checked
Dispersible tablet of alfuzosin hydrochloride (A~H), its dispersing uniformity experimental technique is as follows for prescription: get 2 of this product, put jolting in the 100m1 water, and in 20 ℃ ± 1 ℃ water, all disintegrates and sieve in 3 minutes by No. 2.For details see attached table illustrate 1~8.
2, the mensuration of dispersible tablet of alfuzosin hydrochloride dissolution in vitro
Dispersible tablet of alfuzosin hydrochloride (prescription A~H), its dissolution in vitro experimental technique is as follows: get this product according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2000), 500ml is a solvent with hydrochloric acid solution (9 → 1000), rotating speed is that per minute 50 changes, operation in the time of 30 minutes, is got solution 10ml in accordance with the law, filter, get subsequent filtrate as need testing solution.According to spectrophotography (two appendix IVA of Chinese Pharmacopoeia version in 2000), measure trap at 244nm wavelength place; Precision takes by weighing through 105 ℃ of alfuzosin hydrochloride reference substances that are dried to constant weight an amount of in addition, make the solution that contains 5 μ g among every 1ml with hydrochloric acid solution (9 → 1000) dissolving and quantitative dilution, measure trap, calculate every stripping quantity with method, limit is 80% of a labelled amount, should be up to specification.See description of drawings 1~8 for details.
Table 1: the cumulative in vitro dissolution of prescription A and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 40 54 63 72 85 90
Disperse the time limit 3.0min disintegrate, and can be all by No. 2 sieves
Table 2: the cumulative in vitro dissolution of prescription B and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 46 59 68 77 87 92
Disperse the time limit 2.8min disintegrate, and can be all by No. 2 sieves
Table 3: the cumulative in vitro dissolution of prescription C and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 50 61 72 80 90 94
Disperse the time limit 2.5min disintegrate, and can be all by No. 2 sieves
Table 4: the cumulative in vitro dissolution of prescription D and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 56 67 75 84 91 95
Disperse the time limit 2.0min disintegrate, and can be all by No. 2 sieves
Table 5: the cumulative in vitro dissolution of prescription E and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 53 62 73 81 90 94
Disperse the time limit 2.2min disintegrate, and can be all by No. 2 sieves
Table 6: the cumulative in vitro dissolution of prescription F and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 69 78 86 91 96 97
Disperse the time limit 1.0min disintegrate, and can be all by No. 2 sieves
Table 7: the cumulative in vitro dissolution of prescription G and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 80 92 95 97 97 98
Disperse the time limit 0.7min disintegrate, and can be all by No. 2 sieves
Table 8: the cumulative in vitro dissolution of prescription H and dispersion time limit
Time (min) 5 10 15 20 25 30
Accumulation dissolution (%) 92 96 97 97 97 99
Disperse the time limit 0.1min disintegrate, and can be all by No. 2 sieves
Dispersible tablet of alfuzosin and alfuzosin ordinary tablet healthy volunteer pharmacokinetic are relatively
One, subject enrollment standard: the age is 18~40 years old a healthy male, body weight and standard body weight differ ± and 10%, the experimenter who avoids overweight or kick the beam, comprehensive medical fitness, the mental status is good, tests preceding 2 weeks to cut out any medicine to off-test, non-smoking, is not addicted to drink.
Two, medicine and source
Be subjected to test preparation: dispersible tablet of alfuzosin hydrochloride is provided by Shandong Xinshidai Pharmaceutical Industry Co., Ltd..Specification: the 2.5mg/ sheet, above-mentioned dispersion time limit and dissolution in vitro inspection are all qualified, and meet the clinical research quality standard.
Reference preparation: the alfuzosin hydrochloride sheet is provided specification by Lunan Pharmacy Co. Ltd: the 2.5mg/ sheet.
Three, medication
18 experimenters match in twos according to body weight, meet single port clothes reference preparation alfuzosin hydrochloride sheet (2.5mg) by random digit, meet the twoport clothes to be subjected to test preparation dispersible tablet of alfuzosin hydrochloride (2.5mg), intersect after the week and take medicine.
Four, sample collecting
After the experiment proxima luce (prox. luc) advances light diet evening, begin fasting, test 8:00 in morning on the same day on an empty stomach in accordance with regulations dosage take medicine,, take medicine and can drink water in back 2 hours with reference preparation or taken by test preparation with 250ml eliminating cold for resuscitation water, 4 as a child unified light diet.Every group of experimenter respectively at medicine before and gathered venous blood 3ml behind the medicine in 0.5,1,1.5,2,3,4,6,8,12,18 hour, place the test tube of heparinization, centrifugal 5min, get blood plasma 0.5ml, add the 0.2ml dehydrated alcohol respectively, the 0.1mol/LNaOH solution that adds 0.5ml again, vortex concussion 1 minute, add the 4ml ether and continue concussion 1 minute, centrifugal (2500 rev/mins, 20 minutes) get organic facies, repeat to extract once, put under 40 ℃ of water-baths, N2 dries up, and residue dissolves the sample introduction analysis with 0.5ml acetonitrile-0.02mol/L phosphate buffer (1: 9).
Five, date processing and statistical analysis alfuzosin hydrochloride lower area of blood concentration-time curve (AUC) are worth trapezoidal method calculating, wherein AUC0~12 go out alfuzosin measured value calculating in the plasma sample in the body, and AUC12~∞ calculates according to eliminating phase afterbody lnc-t straight slope k value and 12h point alfuzosin plasma concentration.AUC0~∞ with the alfuzosin ordinary tablet is reference, asks the relative bioavailability of calculating dispersible tablet of alfuzosin.Select the NDST5.0 statistical analysis program, main pharmacokinetic parameter Tmax, Cmax and AUC0~∞ are carried out three-factor analysis of variance and two one-side t check (significance level α=0.05).The results are shown in following table.
The alfuzosin ordinary tablet Dispersible tablet of alfuzosin
Peak time (Tmax, h) blood drug level peak value (Cmax, ngml -1) area under the drug-time curve (AUC, nghml -1) 1.91±0.65 9.15±3.01 39.26±9.12 1.01±0.39 * 12.57±3.21 * 48.35±11.57
Compare P<0.05 with the ordinary tablet group.Significant difference is arranged.
Dispersible tablet of alfuzosin and ordinary tablet compare, and relative bioavailability is 123.15%.
Six, conclusion
Dispersible tablet of alfuzosin hydrochloride of the present invention is compared with existing alfuzosin hydrochloride ordinary tablet, has improved significantly the absorption rate of medicine, so that its clinical efficacy is more rapid; This just lays a good foundation for time and consumption that the patient regulates medication according to symptom. Bioavilability of the present invention also improves a lot, and this may be more obvious in the gerontal patient of gastrointestinal absorption function reduction. In addition, in 18 volunteers, when taking dispersing tablet none generation feel sick, the side effect of digestive tract such as stomachache and diarrhoea; Two when taking ordinary tablet, has 2 volunteers to occur to feel sick and stomachache. This explanation dispersible tablet of alfuzosin hydrochloride GI irritation significantly alleviates.

Claims (2)

1. the pharmaceutical dosage form of an alfuzosin hydrochloride is characterized in that it is a dispersible tablet, wherein contains:
(1) active ingredient hydrochloric acid alfuzosin;
(2) disintegrating agent starch, pregelatinized Starch, carboxymethyl starch sodium, hydroxypropyl cellulose, microcrystalline Cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, hydroxypropyl starch, carboxymethylcellulose calcium, one or more in sodium alginate, hydroxy acid cellulose, sodium carboxymethyl cellulose, methacrylic acid, divinylbenzene copolyesters, IRP-88, guar gum, Herba Xanthii glue, glucosan, the carboxymethylcellulose calcium; The content of described disintegrating agent is 1~80%
2. pharmaceutical dosage form as claimed in claim 1, the amount that it is characterized in that alfuzosin hydrochloride in the every described dispersible tablet of alfuzosin hydrochloride is 0.1~100mg.
CNB2004100907284A 2004-08-30 2004-11-10 Dispersible tablet of alfuzosin hydrochloride Expired - Fee Related CN100372538C (en)

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CN107998090A (en) * 2017-12-30 2018-05-08 威海贯标信息科技有限公司 A kind of Alfuzosin tablet composition
CN108069945A (en) * 2017-12-31 2018-05-25 威海贯标信息科技有限公司 A kind of Alfuzosin novel crystal forms
CN115240875B (en) * 2022-07-25 2023-08-15 湖南慧泽生物医药科技有限公司 Direct estimation method of drug absorption rate constant

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1116524A (en) * 1994-03-21 1996-02-14 合成实验室公司 Formes galeniques a liberation prolongee du chlorhydrate d'alfuzosine

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1116524A (en) * 1994-03-21 1996-02-14 合成实验室公司 Formes galeniques a liberation prolongee du chlorhydrate d'alfuzosine

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
分散片的处方设计和工艺特点. 卢智玲.中国药业,第12卷第7期. 2003 *
分散片的研究进展. 沈岚.中成药,第26卷第2期. 2004 *
良性前列腺增生症治疗新药一阿夫唑嗪. 虞惠康.中国药师,第3卷第4期. 2000 *

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Assignee: LUNNAN BETTER PHARMACEUTICAL Co.,Ltd.

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Contract record no.: 2010370000513

Denomination of invention: Dispersible tablet of alfuzosin hydrochloride

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