CN108704141A - A kind of medicine sustained and controlled release carrier material and preparation method thereof - Google Patents
A kind of medicine sustained and controlled release carrier material and preparation method thereof Download PDFInfo
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- CN108704141A CN108704141A CN201710233001.4A CN201710233001A CN108704141A CN 108704141 A CN108704141 A CN 108704141A CN 201710233001 A CN201710233001 A CN 201710233001A CN 108704141 A CN108704141 A CN 108704141A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of medicine sustained and controlled release carrier materials, include the raw material of following parts by weight:22~35 parts of polyaminoacid, 20~30 parts of polylactic acid, 20~40 parts of framework material, 5~12 parts of starch, 1~3 part of adhesive, 2~5 parts of emulsifier, 0.5~1 part of crosslinking agent, 30~50 parts of deionized water.Inventive formulation science, it matches rigorous, it is raw materials used safe and non-toxic, any toxic side effect will not be generated to body by taking for a long time, it is with good biocompatibility, biodegradability, medicament slow release stability and slow release effect, medicine sustained and controlled release carrier material prepared by the present invention can effectively increase the stability of drug, extend drug treating time, be conducive to improve curative effect of medication, reducing toxic side effect can be completely by organism metabolism with body good biocompatibility, toxic side effect will not be generated to human body, be worthy to be popularized.
Description
Technical field
The present invention relates to medicament slow release technical field more particularly to a kind of medicine sustained and controlled release carrier material and its preparation sides
Method.
Background technology
Traditional administering mode there is a problem that one it is important, even if the drug concentration in human body can be only sustained at it is shorter
Time, the drug concentration in blood or in in-vivo tissue fluctuate up and down it is larger, when and be resistant to agent more than the drug highest of patient
Amount, when and be less than effective dose.Traditional administering mode does not have the effect of should having not only, also will produce side effect sometimes.
Frequent low dose of administration can adjust blood concentration, avoid above-mentioned phenomenon, but enforcement difficulty is larger, patient is often made to be difficult to connect
By.Therefore, the significant of the medicine sustained and controlled release carrier change for capableing of slow release drug ingedient is prepared.Medicament slow release is exactly will be small
Molecular drug and macromolecule carrier, will be small in vivo by the control modes such as spreading, permeating either physically or chemically to combine
Molecular drug is constantly released with concentration appropriate, to achieve the purpose that give full play to efficacy of drugs.It is slow as drug
The material for releasing carrier is the important component of drug controlled release system, is the important substance and shadow for adjusting drug releasing rate
Ring the principal element of drug effect.Medicine sustained and controlled release carrier material commonly used in the prior art it is more or less there are sustained drug release effects
Bad, sustained release process stability is poor, and carrier material and body poor biocompatibility, carrier material biodegradability itself is poor,
It can not be metabolized completely by body completely, take for a long time and toxic side effect etc. easily is generated to human body.Based on above statement, the present invention proposes
A kind of medicine sustained and controlled release carrier material and preparation method thereof.
Invention content
The purpose of the present invention is to solve disadvantages existing in the prior art, and a kind of medicine sustained and controlled release carrier proposed
Material and preparation method thereof.
A kind of medicine sustained and controlled release carrier material includes the raw material of following parts by weight:22~35 parts of polyaminoacid, polylactic acid 20
~30 parts, 20~40 parts of framework material, 5~12 parts of starch, 1~3 part of adhesive, 2~5 parts of emulsifier, 0.5~1 part of crosslinking agent,
30~50 parts of deionized water.
Preferably, a kind of medicine sustained and controlled release carrier material, includes the raw material of following parts by weight:Polyaminoacid 25~
30 parts, 22~28 parts of polylactic acid, 25~35 parts of framework material, 6~10 parts of starch, 1.5~2.5 parts of adhesive, emulsifier 3~4
Part, 0.6~0.8 part of crosslinking agent, 35~45 parts of deionized water.
Preferably, a kind of medicine sustained and controlled release carrier material, includes the raw material of following parts by weight:Polyaminoacid 28
Part, 25 parts of polylactic acid, 30 parts of framework material, 8 parts of starch, 2 parts of adhesive, 3.5 parts of emulsifier, 0.7 part of crosslinking agent, deionized water
40 parts.
Preferably, the framework material is chitosan, cellulose, cellulose protein, collagen, sodium alginate, liver phosphorus
At least three kinds of compositions in ester and lactulose.
Preferably, described adhesive is 2.2~2.8 by mass ratio:1~3:1~5:3.6~6 carboxymethyl cellulose, hydroxyl
Propyl methocel, natural plant gum and deionized water are mixed.
The invention also provides a kind of preparation methods of medicine sustained and controlled release carrier material, include the following steps:
S1, the polyaminoacid of the proportion and polylactic acid are added in melting pot, are brought rapidly up to after 135~155 DEG C, with 10
The rate of~18 DEG C/min, is at the uniform velocity warming up to after raw material is completely melt and keeps the temperature, and 20 are stirred with the rotating speed of 420~480r/min
Then~30min is cooled to 120~140 DEG C, the emulsifier of the proportion is added, and continues stirring to being uniformly mixed, obtains mixture
A;
S2, the mixture A of gained in step S1 is imported into extruder, is 0.25~0.85MPa, temperature 132 in pressure
It is squeezed out under conditions of~154 DEG C, the hybrid particles B that grain size is 0.1~1mm is made through pelleter pelletizing;
S3, the deionized water of the proportion being heated to 90~100 DEG C, the framework material of the proportion is added in heat preservation, with 180~
The rotating speed of 240r/min is cooled to 68~75 DEG C, the starch and crosslinking agent of the proportion is added after stirring 18~30min, continues
Stirring is subsequently placed in being uniformly mixed and dries the mixture C for being 37.5~40.5% to moisture content in the environment of 35~55 DEG C;
S4, the adhesive of hybrid particles B and the proportion of gained in step S2 is added to the mixed of gained in step S3 jointly
It closes in material C, 15~25min is mixed with the rotating speed of 700~800r/min, then fully crushing is through 125~175 mesh sieves
.
A kind of medicine sustained and controlled release carrier material proposed by the present invention, scientific formulation match rigorous, raw materials used safe nothing
Poison, long-term use will not generate any toxic side effect to body, with good biocompatibility, biodegradability, medicine
Object is sustained stability and slow release effect, and the preparation method of medicine sustained and controlled release carrier material proposed by the present invention is simple, reaction
Mild condition, raw material are easy to get, and manufacturing cost is low, and gained medicine sustained and controlled release carrier material can effectively increase the stabilization of drug
Property, extend drug treating time, be conducive to improve curative effect of medication, reduce toxic side effect, medicine sustained and controlled release prepared by the present invention carries
Body material and body good biocompatibility can will not generate toxic side effect to human body, be worthy to be popularized completely by organism metabolism.
Specific implementation mode
The present invention is made further to explain with reference to specific embodiment.
Embodiment one
A kind of medicine sustained and controlled release carrier material proposed by the present invention, includes the raw material of following parts by weight:32 parts of polyaminoacid, poly- breast
30 parts of acid, 38 parts of framework material, 10 parts of starch, 3 parts of adhesive, 5 parts of emulsifier, 1 part of crosslinking agent, 45 parts of deionized water;Wherein
Framework material is the composition of chitosan, cellulose sodium alginate and lactulose;Adhesive is 2.8 by mass ratio:3:5:5.5
Carboxymethyl cellulose, hydroxypropyl methyl cellulose, natural plant gum and deionized water are mixed.
Preparation method includes the following steps:
S1, the polyaminoacid of the proportion and polylactic acid are added in melting pot, are brought rapidly up to after 150 DEG C, with 18 DEG C/
The rate of min, is at the uniform velocity warming up to after raw material is completely melt and keeps the temperature, and is stirred 20min with the rotating speed of 480r/min, then cools down
To 140 DEG C, the emulsifier of the proportion is added, continues stirring to being uniformly mixed, obtains mixture A;
S2, the mixture A of gained in step S1 is imported into extruder, is 0.8MPa, the condition that temperature is 150 DEG C in pressure
The hybrid particles B that grain size is 1mm is made through pelleter pelletizing in lower extrusion;
S3, the deionized water of the proportion is heated to 100 DEG C, the framework material of the proportion is added in heat preservation, with 240r/min
Rotating speed, stir 18min after, be cooled to 75 DEG C, the starch and crosslinking agent of the proportion be added, continue stirring to be uniformly mixed,
It is subsequently placed in and dries the mixture C for being 40% to moisture content in the environment of 55 DEG C;
S4, the adhesive of hybrid particles B and the proportion of gained in step S2 is added to the mixed of gained in step S3 jointly
It closes in material C, with the rotating speed mixing 15min of 800r/min, then fully crushes through 175 mesh sieves to obtain the final product.
Embodiment two
A kind of medicine sustained and controlled release carrier material proposed by the present invention, includes the raw material of following parts by weight:25 parts of polyaminoacid, poly- breast
22 parts of acid, 25 parts of framework material, 6 parts of starch, 1 part of adhesive, 2 parts of emulsifier, 0.5 part of crosslinking agent, 35 parts of deionized water;Wherein
Framework material is the composition of chitosan, cellulose protein, sodium alginate and liver phosphate;Adhesive is 2.2 by mass ratio:1:2:
4 carboxymethyl cellulose, hydroxypropyl methyl cellulose, natural plant gum and deionized water is mixed.
Preparation method includes the following steps:
S1, the polyaminoacid of the proportion and polylactic acid are added in melting pot, are brought rapidly up to after 135 DEG C, with 10 DEG C/
The rate of min, is at the uniform velocity warming up to after raw material is completely melt and keeps the temperature, and is stirred 30min with the rotating speed of 420r/min, then cools down
To 120 DEG C, the emulsifier of the proportion is added, continues stirring to being uniformly mixed, obtains mixture A;
S2, the mixture A of gained in step S1 is imported into extruder, is 0.4MPa, the condition that temperature is 135 DEG C in pressure
The hybrid particles B that grain size is 0.1mm is made through pelleter pelletizing in lower extrusion;
S3, the deionized water of the proportion is heated to 90 DEG C, the framework material of the proportion is added in heat preservation, with 180r/min's
Rotating speed is cooled to 68 DEG C, the starch and crosslinking agent of the proportion is added after stirring 18min, continues stirring to being uniformly mixed, so
It is placed on and dries the mixture C for being 38% to moisture content in the environment of 35 DEG C;
S4, the adhesive of hybrid particles B and the proportion of gained in step S2 is added to the mixed of gained in step S3 jointly
It closes in material C, with the rotating speed mixing 25min of 700r/min, then fully crushes through 125 mesh sieves to obtain the final product.
Embodiment three
A kind of medicine sustained and controlled release carrier material proposed by the present invention, includes the raw material of following parts by weight:30 parts of polyaminoacid, poly- breast
25 parts of acid, 30 parts of framework material, 8 parts of starch, 2 parts of adhesive, 4 parts of emulsifier, 0.6 part of crosslinking agent, 40 parts of deionized water;Wherein
Framework material is the composition of cellulose, collagen, sodium alginate and lactulose;Adhesive is 2.5 by mass ratio:2:3:5
Carboxymethyl cellulose, hydroxypropyl methyl cellulose, natural plant gum and deionized water be mixed.
Preparation method includes the following steps:
S1, the polyaminoacid of the proportion and polylactic acid are added in melting pot, are brought rapidly up to after 145 DEG C, with 14 DEG C/
The rate of min, is at the uniform velocity warming up to after raw material is completely melt and keeps the temperature, and is stirred 25min with the rotating speed of 450r/min, then cools down
To 130 DEG C, the emulsifier of the proportion is added, continues stirring to being uniformly mixed, obtains mixture A;
S2, the mixture A of gained in step S1 is imported into extruder, is 0.5MPa, the condition that temperature is 145 DEG C in pressure
The hybrid particles B that grain size is 0.5mm is made through pelleter pelletizing in lower extrusion;
S3, the deionized water of the proportion is heated to 95 DEG C, the framework material of the proportion is added in heat preservation, with 200r/min's
Rotating speed is cooled to 72 DEG C, the starch and crosslinking agent of the proportion is added after stirring 25min, continues stirring to being uniformly mixed, so
It is placed on and dries the mixture C for being 38% to moisture content in the environment of 45 DEG C;
S4, the adhesive of hybrid particles B and the proportion of gained in step S2 is added to the mixed of gained in step S3 jointly
It closes in material C, with the rotating speed mixing 20min of 750r/min, then fully crushes through 150 mesh sieves to obtain the final product.
The biodegradability of the medicine sustained and controlled release carrier material prepared in inventive embodiments one~tri- is tested respectively;With this
The medicine sustained and controlled release carrier material prepared in inventive embodiments one~tri- is support material, and a concentration of 6% stable, tabletting is added
Slow release tablet is made, tests the medicine sustained and controlled release carrier material to be prepared in the embodiment of the present invention one~tri- respectively as support material
Slow release tablet medicine-releasing performance, obtain following result parameter:
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto, and it is any
Those familiar with the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its invents
Design is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (6)
1. a kind of medicine sustained and controlled release carrier material, which is characterized in that include the raw material of following parts by weight:Polyaminoacid 22~35
Part, 20~30 parts of polylactic acid, 20~40 parts of framework material, 5~12 parts of starch, 1~3 part of adhesive, 2~5 parts of emulsifier, crosslinking
0.5~1 part of agent, 30~50 parts of deionized water.
2. a kind of medicine sustained and controlled release carrier material according to claim 1, which is characterized in that include the original of following parts by weight
Material:25~30 parts of polyaminoacid, 22~28 parts of polylactic acid, 25~35 parts of framework material, 6~10 parts of starch, adhesive 1.5~
2.5 parts, 3~4 parts of emulsifier, 0.6~0.8 part of crosslinking agent, 35~45 parts of deionized water.
3. a kind of medicine sustained and controlled release carrier material according to claim 1, which is characterized in that include the original of following parts by weight
Material:28 parts of polyaminoacid, 25 parts of polylactic acid, 30 parts of framework material, 8 parts of starch, 2 parts of adhesive, 3.5 parts of emulsifier, crosslinking agent
0.7 part, 40 parts of deionized water.
4. a kind of medicine sustained and controlled release carrier material according to claim 1, which is characterized in that the framework material is poly- for shell
At least three kinds of compositions in sugar, cellulose, cellulose protein, collagen, sodium alginate, liver phosphate and lactulose.
5. a kind of medicine sustained and controlled release carrier material according to claim 1, which is characterized in that described adhesive is by mass ratio
It is 2.2~2.8:1~3:1~5:3.6~6 carboxymethyl cellulose, hydroxypropyl methyl cellulose, natural plant gum and deionized water is mixed
Conjunction is made.
6. a kind of preparation method of medicine sustained and controlled release carrier material according to any one of claim 1-5, feature
It is, includes the following steps:
S1, the polyaminoacid of the proportion and polylactic acid are added in melting pot, are brought rapidly up to after 135~155 DEG C, with 10
The rate of~18 DEG C/min, is at the uniform velocity warming up to after raw material is completely melt and keeps the temperature, and 20 are stirred with the rotating speed of 420~480r/min
Then~30min is cooled to 120~140 DEG C, the emulsifier of the proportion is added, and continues stirring to being uniformly mixed, obtains mixture
A;
S2, the mixture A of gained in step S1 is imported into extruder, is 0.25~0.85MPa, temperature 132 in pressure
It is squeezed out under conditions of~154 DEG C, the hybrid particles B that grain size is 0.1~1mm is made through pelleter pelletizing;
S3, the deionized water of the proportion being heated to 90~100 DEG C, the framework material of the proportion is added in heat preservation, with 180~
The rotating speed of 240r/min is cooled to 68~75 DEG C, the starch and crosslinking agent of the proportion is added after stirring 18~30min, continues
Stirring is subsequently placed in being uniformly mixed and dries the mixture C for being 37.5~40.5% to moisture content in the environment of 35~55 DEG C;
S4, the adhesive of hybrid particles B and the proportion of gained in step S2 is added to the mixed of gained in step S3 jointly
It closes in material C, 15~25min is mixed with the rotating speed of 700~800r/min, then fully crushing is through 125~175 mesh sieves
.
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CN201710233001.4A CN108704141A (en) | 2017-04-11 | 2017-04-11 | A kind of medicine sustained and controlled release carrier material and preparation method thereof |
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CN201710233001.4A CN108704141A (en) | 2017-04-11 | 2017-04-11 | A kind of medicine sustained and controlled release carrier material and preparation method thereof |
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2017
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WO2004112752A1 (en) * | 2003-06-26 | 2004-12-29 | Peptron Co., Ltd | Method of preparing mixed formulation of sustained release microspheres by continuous one-step process |
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CN101167697A (en) * | 2006-10-26 | 2008-04-30 | 中国科学院上海药物研究所 | Donepezils compound long-acting slow-releasing and controlled-releasing composition and preparation method thereof |
US20120177740A1 (en) * | 2011-01-12 | 2012-07-12 | Ajou University Industry-Academic Cooperation Foundation | Drug delivery formulation for controlling of initial burst and manufacturing method thereof |
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Non-Patent Citations (2)
Title |
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汤继辉,等: "聚氨基酸作为药物载体的研究进展", 《中国药科大学学报》 * |
王洪新,等: "药物控释载体材料的研究与应用", 《中国组织工程研究与临床康复》 * |
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Application publication date: 20181026 |