CN107998090A - A kind of Alfuzosin tablet composition - Google Patents
A kind of Alfuzosin tablet composition Download PDFInfo
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- CN107998090A CN107998090A CN201711492339.8A CN201711492339A CN107998090A CN 107998090 A CN107998090 A CN 107998090A CN 201711492339 A CN201711492339 A CN 201711492339A CN 107998090 A CN107998090 A CN 107998090A
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- Prior art keywords
- alfuzosin
- recipe quantity
- lactose
- sodium carboxymethyl
- carboxymethyl starch
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of Alfuzosin composition, belong to pharmaceutical technology field.The technical scheme is that：A kind of Alfuzosin tablet composition, in the composition of unit dose, contains 2.5 mg of Alfuzosin, 20 40mg of lactose, 8 16mg of sodium carboxymethyl starch, 30 50mg of microcrystalline cellulose, 12 20mg of calcium citrate, 3 8mg of Macrogol 4000,1.2 1.7mg of magnesium stearate.The present invention provides a kind of Alfuzosin tablet composition of stabilization.
Description
Technical field
The present invention relates to a kind of Alfuzosin composition, belong to pharmaceutical technology field.
Background technology
Hyperplasia of prostate（hyperplasia of prostate）, it is commonly referred to as benign prostatic hyperplasis（benign
Prostatic hyperplasia, BPH）It is one of middle-aging male common disease, it is cumulative with population in the world astogeny onset of illness
It is more.The incidence of hyperplasia of prostate is incremented by with the age, and with advancing age, the symptom such as dysuria increases most of patients therewith
Add.
Hypertrophy of the prostate is also known as hyperplasia of prostate.Symptom is mainly shown as two groups of symptoms, and one kind is irritation sign of bladder;Separately
One kind is the obstructive symptoms produced by hyperplasia forefront adenemphraxis urinary tract.Irritation sign of bladder：Frequent micturition, urgent urination, enuresis nocturna increase and
Urge incontinence.Frequent micturition is the early signal of hyperplasia of prostate, and especially enuresis nocturna number, which increases, more clinical meaning.The disease has three
A main feature：Prostate volume increases;Bladder outlet obstruction;There are the lower urinary tract symptoms such as dysuria, frequent micturition, urgent urination.
Alfuzosin hydrochloride, chemical name：N- [3- [(4- amino -6,7- dimethoxy -2- quinazolyls)-methylamino]
Propyl group] tetrahydrochysene -2- furoyl amine hydrochlorates.For treating benign prostatic hyperplasis illness.2.5mg specification.
Find that Alfuzosin belongs to small dimension preparation, its ordinary tablet is being made in the research process of Alfuzosin ordinary tablet
In standby process, first, uniformity of dosage units is not easy up to standard, second, after long-term storage, slice, thin piece moisture absorption is serious, while related material
Rise protrudes, and influences the safely, effectively property of tablet.
Background technology describes paragraph.
The content of the invention
The object of the present invention is to provide a kind of Alfuzosin tablet composition of stabilization, is provided for clinic safe and effective
Medicine.
Technical solution
The technical scheme is that：A kind of Alfuzosin tablet composition, in the composition of unit dose, contains Alfuzosin
2.5 mg, lactose 20-40mg, sodium carboxymethyl starch 8-16mg, microcrystalline cellulose 30-50mg, calcium citrate 12-20mg, poly- second
Glycol 4000 3-8mg, magnesium stearate 1.2-1.7mg.
Currently preferred technical solution is：A kind of Alfuzosin tablet composition, in the composition of unit dose, containing Ah
Husband's azoles piperazine 2.5 mg, lactose 25-38mg, sodium carboxymethyl starch 10-15mg, microcrystalline cellulose 35-45mg, calcium citrate 14-
18mg, Macrogol 4000 4-7mg, magnesium stearate 1.2-1.7mg..
Currently preferred technical solution is：A kind of Alfuzosin tablet composition, in the composition of unit dose, containing Ah
Husband's azoles piperazine 2.5 mg, lactose 32mg, sodium carboxymethyl starch 14mg, microcrystalline cellulose 40mg, calcium citrate 15mg, polyethylene glycol
4000 6mg, magnesium stearate 1.5mg.
In technical solution of the present invention, the addition of calcium citrate and polyethylene glycol, improves the hygroscopicity of tablet；It is meanwhile poly-
The addition of ethylene glycol avoids the rise in relation to material during storage.
The preparation method of Alfuzosin tablet composition of the present invention, is prepared according to the following steps：
First step Alfuzosin crosses 80 mesh sieves, other auxiliary materials cross 60 mesh sieves respectively；
Second step weighs the Alfuzosin of the first step sieving of recipe quantity, is mixed with the calcium citrate of recipe quantity；Again with two/
Lactose, the sodium carboxymethyl starch of half recipe quantity of one recipe quantity, mix, wetting agent, 40 DEG C of vacuum are used as by the use of 45% ethanol
It is dry, cross 60 mesh sieves.
Particle prepared by 3rd step second step, adds sodium carboxymethyl starch, the lactose of remaining recipe quantity, mixes, then adds
Enter polyethylene glycol, the microcrystalline cellulose of recipe quantity, by the use of 45% ethanol as 40 DEG C of vacuum drying of wetting agent, cross 60 mesh sieves.
Particle prepared by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Preparation method of the present invention, by the use of 45% ethanol as wetting agent, positive effect is played for the stabilization of tablet.
The method of substep granulation of the present invention, improves the uniformity of dosage units of tablet, meanwhile, have for the stabilization of tablet
Certain positive effect.
Beneficial effect：The present invention provides a kind of Alfuzosin tablet composition of stabilization, which is storing
During, there is good moisture resistance energy, store related material for a long time and do not change substantially, the present invention provides peace for patient
Full medicine.
Embodiment 1, Alfuzosin 2.5 g, lactose 20g, sodium carboxymethyl starch 16g, microcrystalline cellulose 50g, calcium citrate
12g, Macrogol 4000 3g, magnesium stearate 1.2g, 1000 g are prepared by the described preparation method of technical solution.
Embodiment 2, Alfuzosin 2.5 g, lactose 40g, sodium carboxymethyl starch 8g, microcrystalline cellulose 30g, calcium citrate
20g, Macrogol 4000 8g, magnesium stearate 1.7g, 1000 are prepared by the described preparation method of technical solution.
Embodiment 3, Alfuzosin 2.5g, lactose 32g, sodium carboxymethyl starch 14g, microcrystalline cellulose 40g, calcium citrate
15g, Macrogol 4000 6g, magnesium stearate 1.5g, 1000 are prepared by the described preparation method of technical solution.
Reference examples 1,3 prescription of embodiment, cut calcium citrate, and corresponding weight is supplemented with lactose.It is specific as follows：
Alfuzosin 2.5g, lactose 47g, sodium carboxymethyl starch 14g, microcrystalline cellulose 40g, Macrogol 4000 6g, stearic acid
Magnesium 1.5g, 1000 are prepared by following preparation methods.
First step Alfuzosin crosses 80 mesh sieves, other auxiliary materials cross 60 mesh sieves respectively；
Second step weigh recipe quantity the first step sieving Alfuzosin, then with the lactose of half recipe quantity, half
The sodium carboxymethyl starch of recipe quantity, mixes, and by the use of 45% ethanol as wetting agent, 40 DEG C of vacuum drying, cross 60 mesh sieves.
Particle prepared by 3rd step second step, adds sodium carboxymethyl starch, the lactose of remaining recipe quantity, mixes, then adds
Enter polyethylene glycol, the microcrystalline cellulose of recipe quantity, by the use of 45% ethanol as 40 DEG C of vacuum drying of wetting agent, cross 60 mesh sieves.
Particle prepared by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Reference examples 2,3 prescription of embodiment, cut polyethylene glycol, and corresponding weight is supplemented by lactose.It is specific as follows：
Prescription：Alfuzosin 2.5g, lactose 38g, sodium carboxymethyl starch 14g, microcrystalline cellulose 40g, calcium citrate 15g, it is stearic
Sour magnesium 1.5g, 1000 are prepared by following preparation methods.
First step Alfuzosin crosses 80 mesh sieves, other auxiliary materials cross 60 mesh sieves respectively；
Second step weighs the Alfuzosin of the first step sieving of recipe quantity, is mixed with the calcium citrate of recipe quantity；Again with two/
Lactose, the sodium carboxymethyl starch of half recipe quantity of one recipe quantity, mix, wetting agent, 40 DEG C of vacuum are used as by the use of 45% ethanol
It is dry, cross 60 mesh sieves.
Particle prepared by 3rd step second step, adds sodium carboxymethyl starch, the lactose of remaining recipe quantity, mixes, then adds
Enter the microcrystalline cellulose of recipe quantity, by the use of 45% ethanol as 40 DEG C of vacuum drying of wetting agent, cross 60 mesh sieves.
Particle prepared by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Reference examples 3,3 prescription of embodiment, one-step method granulation.It is specific as follows：
Alfuzosin 2.5g, lactose 32g, sodium carboxymethyl starch 14g, microcrystalline cellulose 40g, calcium citrate 15g, polyethylene glycol
4000 6g, magnesium stearate 1.5g, 1000 are prepared by following preparation methods
First step Alfuzosin crosses 80 mesh sieves, other auxiliary materials cross 60 mesh sieves respectively；
Second step weighs the Alfuzosin of the first step sieving of recipe quantity, is mixed with the calcium citrate of recipe quantity；Again with recipe quantity
Lactose, sodium carboxymethyl starch, polyethylene glycol, microcrystalline cellulose, mix, done by the use of 45% ethanol as wetting agent, 40 DEG C of vacuum
It is dry, cross 60 mesh sieves.
Particle prepared by 3rd step second step, adds the magnesium stearate of recipe quantity, tabletting.
Test example 1, respectively Example 1-3 and each 100 of reference examples 1-3 products, it is aluminum-plastic packaged, it is placed in climatic chamber
In, 30 DEG C, relative humidity 75%, is stored 12 months, is taken out, and observes slice, thin piece appearance, takes complete slice, thin piece to measure related material（It is high
Effect liquid phase chromatogram method）Degree.Measure situation is recorded in table 1.
Table 1
1 data explanation of table：Product of the embodiment of the present invention is stable during storage, its slice, thin piece appearance and related material are almost
Do not change；And the related material of reference examples product is elevated, and tablet has different degrees of hygroscopic effect, than if any point
Or become loose, it is obvious to illustrate that technical solution of the present invention has played the stabilization of tablet.It is various in technical solution of the present invention
The reasonable compatibility of component, and and preparation method combination, very prominent effect is played for the stabilization of tablet, for clinic
Provide a kind of composition of safety and stability.
Test example 2, the method by States Pharmacopoeia specifications, the content for measuring 3 product of embodiment 1-3 and reference examples respectively are uniform
Degree, high-efficient liquid phase chromatogram determining content data records are in table 2.
Table 2
| 1 product of embodiment | 2 product of embodiment | 3 product of embodiment | 3 product of reference examples | |
| Average content, % | 99.98 | 99.98 | 99.97 | 99.97 |
| Relative standard deviation RSD, % | 1.2 | 1.2 | 1.2 | 3.1 |
2 data of table illustrate that the prepared tablet of 3 one-step method of reference examples granulation, uniformity of dosage units seriously exceeds the 2.0 of States Pharmacopoeia specifications
Standard.Illustrate preparation method of the present invention, for the stabilization of uniformity of dosage units, play prominent effect.
Claims (4)
- A kind of 1. Alfuzosin tablet composition, it is characterised in that in the composition of unit dose, containing 2.5 mg of Alfuzosin, Lactose 20-40mg, sodium carboxymethyl starch 8-16mg, microcrystalline cellulose 30-50mg, calcium citrate 12-20mg, Macrogol 4000 3-8mg, magnesium stearate 1.2-1.7mg.
- 2. according to Alfuzosin tablet composition described in claim 1, it is characterised in that in the composition of unit dose, contain Ah Husband's azoles piperazine 2.5 mg, lactose 25-38mg, sodium carboxymethyl starch 10-15mg, microcrystalline cellulose 35-45mg, calcium citrate 14- 18mg, Macrogol 4000 4-7mg, magnesium stearate 1.2-1.7mg.
- 3. according to Alfuzosin tablet composition described in claim 1, it is characterised in that in the composition of unit dose, contain Ah Husband's azoles piperazine 2.5 mg, lactose 32mg, sodium carboxymethyl starch 14mg, microcrystalline cellulose 40mg, calcium citrate 15mg, polyethylene glycol 4000 6mg, magnesium stearate 1.5mg.
- 4. the preparation method of Alfuzosin tablet composition described in claim 1, it is characterised in that be prepared according to the following steps：First step Alfuzosin crosses 80 mesh sieves, other auxiliary materials cross 60 mesh sieves respectively；Second step weighs the Alfuzosin of the first step sieving of recipe quantity, is mixed with the calcium citrate of recipe quantity；Again with two/ Lactose, the sodium carboxymethyl starch of half recipe quantity of one recipe quantity, mix, wetting agent, 40 DEG C of vacuum are used as by the use of 45% ethanol It is dry, cross 60 mesh sieves；Particle prepared by 3rd step second step, adds sodium carboxymethyl starch, the lactose of remaining recipe quantity, mixes, add place Polyethylene glycol, the microcrystalline cellulose just measured, by the use of 45% ethanol as 40 DEG C of vacuum drying of wetting agent, cross 60 mesh sieves；Particle prepared by the 3rd step of 4th step, adds the magnesium stearate of recipe quantity, tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711492339.8A CN107998090A (en) | 2017-12-30 | 2017-12-30 | A kind of Alfuzosin tablet composition |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711492339.8A CN107998090A (en) | 2017-12-30 | 2017-12-30 | A kind of Alfuzosin tablet composition |
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| Publication Number | Publication Date |
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| CN107998090A true CN107998090A (en) | 2018-05-08 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN201711492339.8A Pending CN107998090A (en) | 2017-12-30 | 2017-12-30 | A kind of Alfuzosin tablet composition |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4315007A (en) * | 1978-02-06 | 1982-02-09 | Synthelabo | 4-Amino-6,7-dimethoxyquinazol-2-yl alkylenediamines |
| CN1634066A (en) * | 2004-08-30 | 2005-07-06 | 鲁南制药股份有限公司 | Dispersible tablet of alfuzosin hydrochloride |
| CN102475690A (en) * | 2010-11-30 | 2012-05-30 | 安国药品株式会社 | Alfuzosin hydrochloride-containing slow-release tablets |
| CN105287422A (en) * | 2015-12-07 | 2016-02-03 | 黑龙江省智诚医药科技有限公司 | Alfuzosin hydrochloride sustained release tablets and preparation method thereof |
-
2017
- 2017-12-30 CN CN201711492339.8A patent/CN107998090A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4315007A (en) * | 1978-02-06 | 1982-02-09 | Synthelabo | 4-Amino-6,7-dimethoxyquinazol-2-yl alkylenediamines |
| CN1634066A (en) * | 2004-08-30 | 2005-07-06 | 鲁南制药股份有限公司 | Dispersible tablet of alfuzosin hydrochloride |
| CN102475690A (en) * | 2010-11-30 | 2012-05-30 | 安国药品株式会社 | Alfuzosin hydrochloride-containing slow-release tablets |
| CN105287422A (en) * | 2015-12-07 | 2016-02-03 | 黑龙江省智诚医药科技有限公司 | Alfuzosin hydrochloride sustained release tablets and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 于晓蕾等: "盐酸阿夫唑嗪口崩片的制备及体外溶出度影响因素考察", 《齐鲁药事》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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Application publication date: 20180508 |