CN114209668B - Alfuzosin hydrochloride sustained release preparation and preparation method thereof - Google Patents
Alfuzosin hydrochloride sustained release preparation and preparation method thereof Download PDFInfo
- Publication number
- CN114209668B CN114209668B CN202210038041.4A CN202210038041A CN114209668B CN 114209668 B CN114209668 B CN 114209668B CN 202210038041 A CN202210038041 A CN 202210038041A CN 114209668 B CN114209668 B CN 114209668B
- Authority
- CN
- China
- Prior art keywords
- release
- lubricant
- preparation
- plasticizer
- alfuzosin hydrochloride
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Classifications
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- 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
-
- 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
-
- 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
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Urology & Nephrology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the field of sustained-release preparations, and particularly relates to an alfuzosin hydrochloride sustained-release preparation and a preparation method thereof. The alfuzosin hydrochloride sustained-release preparation provided by the invention comprises a drug-loaded pellet, a sustained-release coating layer and a medicinal auxiliary material layer, wherein the drug-loaded pellet comprises alfuzosin hydrochloride, a filler, a plasticizer, a sustained-release framework material, a lubricant and a stabilizer; the slow release coating layer comprises a film forming material, a plasticizer, a lubricant and purified water. The pharmaceutic adjuvant layer comprises a filling agent, a disintegrating agent, a flavoring agent, a lubricating agent and a glidant.
Description
Technical Field
The invention belongs to the field of sustained-release preparations, and particularly relates to an alfuzosin hydrochloride sustained-release preparation and a preparation method thereof.
Background
Prostatic Hyperplasia (BPH), also known as benign prostatic hypertrophy, is a common disease in middle-aged and elderly men, and the cause of the disease is related to imbalance between androgens and estrogens in the human body. The lesions originate from glandular tissues, connective tissues and smooth muscle tissues of the medial lobe or lateral lobe under the mucosa of the posterior urethra, and form mixed spherical nodules. Hyperplasia of the two side lobes and the middle lobe is obvious and protrudes into the bladder or urethra to press the neck of the bladder or urethra, causing obstruction of the lower urinary tract
Alfuzosin hydrochloride (alfuzosine hcl) is a potent blocker of the alpha-adrenergic receptor and is a widely used agent for the treatment of benign prostate enlargement. However, alfuzosin hydrochloride has a short half-life in vivo and a very strong absorption rate in the duodenum and jejunum phases. Therefore, the preparation developed at the beginning requires administration 2 to 3 times per day, which is very inconvenient. The alfuzosin hydrochloride oral sustained release preparation is constantly and slowly released at a predetermined speed after administration, unlike the conventional preparation which rapidly releases the drug. Compared with corresponding common preparations such as quick-release tablets, capsules and oral liquid, the preparation can improve the compliance of patients and increase the curative effect of medicaments. The sustained-release preparation has the main advantages of reducing the medicine taking frequency and avoiding the peak valley phenomenon of blood concentration when taking the common preparation. The sustained-release preparation can keep the blood concentration stable in the effective blood concentration range in a relatively long time, thereby improving the safety of the medicament.
Disclosure of Invention
In order to overcome the defects of the prior art, the first purpose of the invention is to provide an alfuzosin hydrochloride sustained-release preparation with high stability, excellent release effect and high content uniformity, which adopts skeleton type and membrane control type cooperative control, is favorable for the release of the medicament, avoids the peak valley phenomenon of blood concentration, ensures that the alfuzosin hydrochloride achieves the sustained release effect, solves the problems of poor release effect, low stability and content uniformity and difficult administration of part of patients, improves the safety and effectiveness of the medicament, increases the application range of the medicament, has good reproducibility of a release curve and is suitable for industrial mass production.
Specifically, the technical scheme of the invention is as follows:
the invention provides an alfuzosin hydrochloride sustained-release preparation which comprises drug-carrying pellets, a sustained-release coating layer and a medicinal auxiliary material layer, wherein the drug-carrying pellets comprise alfuzosin hydrochloride, a filling agent, a plasticizer, a sustained-release framework material, a lubricant and a stabilizer; the pharmaceutic adjuvant layer comprises a filling agent, a disintegrating agent, a flavoring agent, a lubricating agent and a glidant.
Further, the plasticizer is one or more of propylene glycol, glyceryl triacetate, glyceryl citrate and diacetyl monoglyceride; the filler is one or more of dextrin, lactose, starch, microcrystalline cellulose and sucrose; the lubricant is calcium stearate and/or talcum powder.
Further, the plasticizer is one or more of glyceryl triacetate, glyceryl citrate and diacetyl monoglyceride.
Furthermore, the slow-release framework material is ethyl cellulose or hydroxypropyl methyl cellulose.
Further, the film forming material is an aqueous dispersion of ethyl acrylate-methyl methacrylate copolymer, preferably EudragitNE30D.
Specifically, the stabilizer is trehalose and/or xanthan gum, preferably trehalose: xanthan gum = 1..
Specifically, the drug-loaded pellet comprises the following components in percentage: preferably, the alfuzosin hydrochloride comprises 5% of alfuzosin hydrochloride, 85% of filling agent, 1% of plasticizer, 4% of slow-release framework material, 3% of lubricant and 2% of stabilizer.
Specifically, the slow-release coating layer comprises the following components in percentage: 40-60% of film forming material, 1-5% of plasticizer, 1-6% of lubricant and 30-55% of purified water; preferably 50% of film-forming material, 3% of plasticizer, 4% of lubricant and 43% of purified water.
The second purpose of the invention is to provide a method for preparing alfuzosin hydrochloride sustained release preparation, which comprises the steps of preparing pellets containing main drugs by an extrusion spheronization process, drying the pellets by a drying box, and performing bottom spray coating in a fluidized bed.
The prepared drug-loaded pellets are prepared by adopting an extrusion and spheronization process, and the drug-loaded pellets are coated by adopting a fluidized bed, and the method specifically comprises the following steps:
(1) Preparing a drug-loaded pill: pre-dissolving alfuzosin hydrochloride in purified water, pouring the alfuzosin hydrochloride, a filler, a lubricant and a stabilizer into a granulator, mixing, adding a slow-release framework material, a plasticizer and a proper amount of purified water, granulating, extruding, rounding and drying;
(2) Preparing a slow-release coating layer;
(3) And (4) tabletting the pellets.
Specifically, the rounding process in the step (1) is rotating speed of the turntable of 100rmp for 10min; obtaining the micro-pill with the granularity range of 0.4-0.8mm; the preparation of the slow-release coating layer in the step (2) comprises the following steps: adding a lubricant and a plasticizer into purified water, homogenizing and stirring, pouring a film-forming material into the purified water, and stirring to obtain a coating solution, wherein the coating weight is increased by 3.0-5.0%. The pellet tabletting process in the step (3): mixing the drug-loaded pellets with filler, disintegrant, correctant, lubricant and glidant, and tabletting.
Compared with the prior art, the invention has the beneficial effects that:
(1) The double-layer control is adopted, so that the release of the medicine is favorably controlled, and the medicine effect is more durable.
(2) The type and the proportion of the plasticizer are optimized, the flexibility is enhanced, so that the medicine is not easy to be brittle, and the medicine quality is improved;
(3) The kind and proportion of the stabilizer are optimized, so that the stability of the medicine is improved, the content uniformity is high, and the reproducibility of a release curve is good;
(4) Extrusion spheronization is adopted to prepare drug-loaded pellets, fluidized bed coating is adopted, the spheronization process and the coating weight increasing range are optimized, and the uniformity of the drug content is improved.
(5) By adopting a pellet tabletting process, the material fluidity is good, the dosage of the finished product is controllable, and the application range is wider.
Drawings
FIG. 1 in vitro cumulative Release profiles of examples 1-5 of the invention
FIG. 2 graph of in vitro cumulative release of comparative examples 1 to 7 of the present invention
Detailed Description
In order to make the purpose and technical solution of the present invention more clear, the present invention is further described with reference to the following examples, but the scope of the present invention is not limited to these examples, and the examples are only used for explaining the present invention. It will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the true scope of the invention.
Example 1:20000 tablet
Pellet prescription
The preparation method of the pellet comprises the following steps:
(1) Preparing a soft material: dissolving alfuzosin hydrochloride in purified water in advance, uniformly mixing a filling agent, a lubricating agent and a stabilizing agent in a granulator, mixing, adding a solution containing raw materials, adding a slow-release framework material, a plasticizer and a proper amount of purified water, and granulating to obtain a proper soft material;
(2) Extruding: pouring the soft material obtained in the step (1) into an extruder for extrusion to obtain crushed particles;
(3) Rounding: pouring the particles obtained in the step (2) into a rounding machine for rounding, wherein the rotating speed of a rotating disc is 100rmp and 10min;
(4) And (3) drying: drying the wet pellets obtained in the step (3) in a drying box to obtain dry pellets;
(5) Coating: preparing a coating solution to coat, wherein the weight of the coating is increased by 4%;
(6) And (3) pellet tabletting: mixing the above pellet with filler, disintegrant, correctant, lubricant and glidant, and tabletting.
And (3) pellet tabletting:
| components | Content (g) |
| Pellet | 144 |
| Microcrystalline cellulose 102 | 86.4 |
| Sodium carboxymethyl starch | 23.04 |
| Colloidal silica | 5.76 |
| Calcium stearate | 7.2 |
| Sucrose | 21.6 |
The preparation method comprises the following steps: mixing the above pellet with filler, disintegrant, correctant, lubricant and glidant, and tabletting.
Example 2: 50000A tablet
The pellet formulation and preparation process are the same as example 1
And (3) pellet tabletting:
| components | Content (g) |
| Pellet | 152 |
| Microcrystalline cellulose 102 | 82 |
| Sodium carboxymethyl starch | 28 |
| |
4 |
| Calcium stearate | 9 |
| Sucrose | 25 |
The preparation method comprises the following steps: the preparation method is the same as that of example 1.
Example 3:20000 tablet
Pellet prescription
The preparation process is the same as example 1
And (3) pellet tabletting:
the preparation method comprises the following steps: the preparation method is the same as that of example 1.
Example 4:20000 tablet
Pellet prescription
The preparation process is the same as example 1
And (3) pellet tabletting:
the preparation method comprises the following steps: the preparation method is the same as that of example 1.
Example 5:20000 pieces
Pellet prescription
The preparation process is the same as example 1
And (3) pellet tabletting:
the preparation method comprises the following steps: the preparation method is the same as that of example 1.
Comparative example 1:20000 tablet
Pellet prescription
The preparation process is the same as example 1
And (3) pellet tabletting:
the preparation method comprises the following steps: the preparation method is the same as that of example 1.
Comparative example 2:20000 tablet
Pellet prescription
The preparation process is the same as in example 1
And (3) pellet tabletting:
| components | Content (g) | Ratio of occupation of |
| Pellet | 144 | 50 |
| Microcrystalline cellulose 102 | 86.4 | 30 |
| Sodium carboxymethyl starch | 23.04 | 8 |
| Colloidal silica | 5.76 | 2 |
| Calcium stearate | 7.2 | 2.5 |
| Sucrose | 21.6 | 7.5 |
The preparation method comprises the following steps: the preparation method is the same as that of example 1.
Comparative example 3:20000 tablet
Pellet prescription
The preparation process is the same as example 1
The pellet tabletting prescription and the preparation method are as follows: the same recipe as in example 1 and the preparation process as in example 1.
Comparative example 4: 50000A tablet
Pellet prescription
The preparation method comprises the following steps:
(1) Preparing a soft material: dissolving alfuzosin hydrochloride in purified water in advance, uniformly mixing half of the formula amount of a filling agent and a stabilizing agent in a granulator, mixing, adding a solution containing raw materials, adding a slow-release framework material, a plasticizer and a proper amount of purified water, and granulating to obtain a proper soft material;
(2) Extruding: pouring the soft material obtained in the step (1) into an extruder for extrusion to obtain crushed particles;
(3) Rounding: pouring the particles obtained in the step (2) into a rounding machine for rounding, wherein the rotating speed of a rotating disc is 100rmp and 10min;
(4) And (3) drying: drying the wet pellets obtained in the step (3) in a drying box to obtain dry pellets;
(5) Coating: preparing a coating liquid for coating, wherein the weight of the coating is increased by 4%;
(6) And (3) pellet tabletting: mixing the above pellet with the rest filler, sucrose, and lubricant, and tabletting.
Comparative example 5:20000 tablet
Pellet prescription
The preparation process is the same as in example 1
And (3) pellet tabletting:
| components | Content (g) |
| Micro-pills | 144 |
| Microcrystalline cellulose 102 | 86.4 |
| Sodium carboxymethyl starch | 23.04 |
| Colloidal silica | 5.76 |
| Calcium stearate | 7.2 |
| Sucrose | 21.6 |
The preparation method comprises the following steps: the preparation method is the same as that of example 1.
Comparative example 6:20000 tablet
Pellet prescription
And (3) pellet tabletting:
| components | Content (g) |
| Micro-pills | 144 |
| Microcrystalline cellulose 102 | 86.4 |
| Sodium carboxymethyl starch | 23.04 |
| Colloidal silica | 5.76 |
| Calcium stearate | 7.2 |
| Sucrose | 21.6 |
Preparation method
(1) Preparing a soft material: dissolving alfuzosin hydrochloride in purified water in advance, uniformly mixing and mixing a filler, a lubricant and a stabilizer in a granulator, then adding a solution containing raw materials, adding a proper amount of purified water, and granulating to obtain a proper soft material;
(2) Extruding: pouring the soft material obtained in the step (1) into an extruder for extrusion to obtain crushed particles;
(3) Rounding: pouring the particles obtained in the step (2) into a rounding machine for rounding, wherein the rotating speed of a rotating disc is 100rmp and 10min;
(4) And (3) drying: drying the wet pellets obtained in the step (3) in a drying box to obtain dry pellets;
(5) Coating: preparing a coating liquid for coating, wherein the weight of the coating is increased by 4%;
(6) And (3) pellet tabletting: mixing the above drug-loaded pellet with filler, disintegrant, correctant, lubricant and glidant, and tabletting.
Comparative example 7:50000 granules
Pellet prescription
The preparation process is the same as in example 1
And (3) pellet tabletting:
| components | Content (g) |
| Pellet | 152 |
| Microcrystalline cellulose 102 | 85.3 |
| Sodium carboxymethyl starch | 24.2 |
| Colloidal silica | 8.6 |
| Calcium stearate | 6.6 |
| Sucrose | 18.9 |
The preparation method comprises the following steps: the preparation method is the same as that of example 1.
Verification examples
Release test
The release rate is determined by dissolution and release rate determination method (second method of 0931 in the four-part general rules of the 2020 edition of Chinese pharmacopoeia). Using a second method, 900ml of 0.1mol/L hydrochloric acid solution as a dissolution medium, and a rotation speed of 50 rpm, 10ml of the solution was sampled for 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, and 14 hours, respectively, according to the method. Filtering, timely supplementing 10ml of dissolution medium with the same temperature in an operation container, precisely measuring 5ml of subsequent filtrate, placing in a 100ml measuring flask, and diluting to scale with 0.1mol/L hydrochloric acid solution to obtain a sample solution; taking a proper amount of riluzole reference substance, precisely weighing, adding 0.1mol/L hydrochloric acid solution for dissolving, and quantitatively diluting to prepare a solution containing about 10 mu g of the riluzole reference substance in each 1ml, wherein the solution is used as the reference substance solution. Respectively taking the test solution and the reference solution, respectively measuring absorbance at 254nm wavelength according to ultraviolet-visible spectrophotometry (0401 in the four parts of the pharmacopoeia 2015 of China), and calculating the release amount of each tablet at different time.
TABLE 1 in vitro cumulative Release
Content uniformity
The content and content uniformity were measured by UV-visible spectrophotometry (national pharmacopoeia 2015 edition four parts general rules 0401). Test solution: taking 20 tablets of the product, precisely weighing, grinding, precisely weighing a proper amount of fine powder (about equivalent to 50mg of riluzole), putting the fine powder into a 250ml measuring flask, adding 0.1mol/L hydrochloric acid solution to dissolve the riluzole (ultrasonic if necessary) and dilute the riluzole to a scale, shaking up, filtering, precisely weighing 5ml of subsequent filtrate, putting the subsequent filtrate into a 100ml measuring flask, diluting the subsequent filtrate to the scale with 0.1mol/L hydrochloric acid solution, and shaking up. Control solution: taking a proper amount of riluzole reference substance, precisely weighing, adding 0.1mol/L hydrochloric acid solution for dissolving, and quantitatively diluting to prepare a solution containing about 10 mu g of riluzole in each 1 ml. The determination method comprises the following steps: taking the test solution and the reference solution, respectively measuring absorbance at 254nm wavelength, and calculating.
TABLE 2 content uniformity table
Friability test
The tablets were taken at a weight of 0.65g or less so that the total weight was about 6.5g. The powder falling off the tablets was blown off with a blower, precisely weighed, placed in a cylinder and rotated 100 times. Taking out, removing powder by the same method, precisely weighing, and calculating the mass percentage of the fine powder in the pellet.
Claims (4)
1. An alfuzosin hydrochloride sustained-release preparation comprises drug-loaded pellets, a sustained-release coating layer and a medicinal auxiliary material layer, and is characterized in that the drug-loaded pellets comprise alfuzosin hydrochloride, a filler, a plasticizer, a sustained-release framework material, a lubricant and a stabilizer, wherein the filler is one or more of starch, microcrystalline cellulose and sucrose; the lubricant is calcium stearate and/or talcum powder, the slow-release framework material is ethyl cellulose or hydroxypropyl methyl cellulose, and the stabilizer is trehalose and/or xanthan gum, wherein the alfuzosin hydrochloride accounts for 5 percent, the filler accounts for 85 percent, the plasticizer accounts for 1 percent, the slow-release framework material accounts for 4 percent, the lubricant accounts for 3 percent, and the stabilizer accounts for 2 percent; the slow release coating layer comprises a film forming material, a plasticizer and a lubricant; the film forming material is Eudragit NE30D, wherein the film forming material comprises, by weight, 40% -60% of the film forming material, 1% -5% of the plasticizer, 1% -6% of the lubricant and 30% -55% of purified water, and the pharmaceutic adjuvant layer comprises a filling agent, a disintegrating agent, a flavoring agent, a lubricant and a flow aid.
2. The alfuzosin hydrochloride sustained release formulation according to claim 1, wherein the sustained release coating layer comprises in weight percent: 50% of film forming material, 3% of plasticizer, 4% of lubricant and 43% of purified water.
3. A process for the preparation of an alfuzosin hydrochloride sustained release formulation according to claim 1, characterized in that it comprises the following steps:
(1) Preparing a medicine-carrying pill: pre-dissolving alfuzosin hydrochloride in purified water, pouring the alfuzosin hydrochloride, a filler, a lubricant and a stabilizer into a granulator, mixing, adding a slow-release framework material, a plasticizer and a proper amount of purified water, granulating, extruding, rounding and drying;
(2) Preparing a slow-release coating layer, and coating by a fluidized bed;
(3) And (4) tabletting the pellets.
4. The method according to claim 3, wherein the rotating disc rotating speed in the spheronization process in the step (1) is 100rmp and 10min, so that the particle size of the pellets is in a range of 0.4-0.8mm; the preparation process of the slow-release coating solution in the step (2) is as follows: adding a lubricant and a plasticizer into purified water, stirring, pouring a film-forming material, and stirring to obtain a coating solution, wherein the coating weight is increased by 3.0-5.0%; the pellet tabletting process in the step (3): mixing the drug-loaded pellets with filler, disintegrant, correctant, lubricant and glidant, and tabletting.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210038041.4A CN114209668B (en) | 2022-01-13 | 2022-01-13 | Alfuzosin hydrochloride sustained release preparation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202210038041.4A CN114209668B (en) | 2022-01-13 | 2022-01-13 | Alfuzosin hydrochloride sustained release preparation and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN114209668A CN114209668A (en) | 2022-03-22 |
| CN114209668B true CN114209668B (en) | 2023-01-31 |
Family
ID=80708164
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202210038041.4A Active CN114209668B (en) | 2022-01-13 | 2022-01-13 | Alfuzosin hydrochloride sustained release preparation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114209668B (en) |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| UA69374C2 (en) * | 1996-08-29 | 2004-09-15 | Санофі-Сентелябо | Tableted dosage form for delayed release of alfusosin hydrochloride |
| FR2820319B3 (en) * | 2001-02-08 | 2003-12-05 | Ellipse Pharmaceuticals | PROCESS FOR PRODUCING A FLOATING TABLET INCLUDING ALFUZOSINE AND TABLET OBTAINED |
| CN101095681B (en) * | 2007-07-13 | 2011-04-20 | 沈阳药大制剂新技术有限公司 | Alfuzosin Hydrochloride permeating pump type controlled-release preparation and method for preparing the same |
| CN101756991B (en) * | 2008-12-24 | 2012-08-29 | 鲁南制药集团股份有限公司 | Sustained-release pills of alfuzosin hydrochloride |
| CN102475690B (en) * | 2010-11-30 | 2016-06-01 | 安国药品株式会社 | Include the slow releasing tablet of alfuzosin hydrochloride |
| CN106727434A (en) * | 2015-11-19 | 2017-05-31 | 哈尔滨圣吉药业股份有限公司 | A kind of alfuzosin hydrochloride sustained release pellet and preparation method thereof |
| 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 |
-
2022
- 2022-01-13 CN CN202210038041.4A patent/CN114209668B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN114209668A (en) | 2022-03-22 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP4017664B2 (en) | Pharmaceutical composition of conjugated estrogens and methods of use thereof | |
| WO2022012172A1 (en) | Oral sustained-release composition for insoluble drug, and preparation method thereof | |
| CN115581686B (en) | Preparation method of pregabalin capsule and pregabalin capsule | |
| CN111135153A (en) | Ursodeoxycholic acid capsule and preparation method thereof | |
| WO2021042278A1 (en) | Multi-unit sustained-release acipimox pellet tablet and preparation method therefor | |
| CN113456604B (en) | Sildenafil citrate orally disintegrating tablet and preparation method thereof | |
| CN114209668B (en) | Alfuzosin hydrochloride sustained release preparation and preparation method thereof | |
| CN102283816B (en) | Silodosin sustained-release tablet and preparation method thereof | |
| CN112315927A (en) | Paliperidone sustained-release orally disintegrating tablet and preparation method thereof | |
| CN100488515C (en) | Ground erythromycin enteric micropill and its preparation method | |
| JP2010540491A (en) | Tamsulosin hydrochloride sustained-release tablet and method for producing the same | |
| CN101057837B (en) | Dextro-ketoprofen enteric coated preparation and its preparation method | |
| CN109646417A (en) | A kind of Trimetazidine sustained release tablets and preparation method thereof | |
| CN111346064B (en) | Rivaroxaban tablet and preparation method thereof | |
| EP3431107A1 (en) | Pharmaceutical composition particles and orally disintegrating preparation including same | |
| CN112675146A (en) | Doku sodium micro-pills and preparation method thereof | |
| CN114948883A (en) | Digoxin micro tablet and preparation method thereof | |
| CN109833299B (en) | Micronized roxatidine acetate medicinal salt pellet as well as preparation method and application thereof | |
| CN115337285A (en) | Alfuzosin hydrochloride sustained-release pellet capsule and preparation method thereof | |
| CN117442577B (en) | Candesartan cilexetil microchip and preparation method and application thereof | |
| CN116473942A (en) | Loratadine sustained-release capsule and preparation method thereof | |
| CN104490790A (en) | Cefuroxime axetil solid dispersion-coated composition and preparation method thereof | |
| CN117815195B (en) | JAK inhibitor composition and preparation process thereof | |
| JP7182550B2 (en) | Pharmaceutical composition particles, orally disintegrating preparation containing same, and method for producing pharmaceutical composition particles | |
| JP7547723B2 (en) | Abiraterone acetate-containing preparations |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |