CN112494443A - Accurate sustained-release tablet and preparation method thereof - Google Patents
Accurate sustained-release tablet and preparation method thereof Download PDFInfo
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- CN112494443A CN112494443A CN202011452650.1A CN202011452650A CN112494443A CN 112494443 A CN112494443 A CN 112494443A CN 202011452650 A CN202011452650 A CN 202011452650A CN 112494443 A CN112494443 A CN 112494443A
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- 239000007939 sustained release tablet Substances 0.000 title claims abstract description 32
- 238000002360 preparation method Methods 0.000 title claims abstract description 11
- 239000010410 layer Substances 0.000 claims abstract description 25
- 150000004676 glycans Chemical class 0.000 claims abstract description 20
- 229920001282 polysaccharide Polymers 0.000 claims abstract description 20
- 239000005017 polysaccharide Substances 0.000 claims abstract description 20
- 239000003814 drug Substances 0.000 claims abstract description 18
- 229940079593 drug Drugs 0.000 claims abstract description 18
- 238000013268 sustained release Methods 0.000 claims abstract description 18
- 239000012730 sustained-release form Substances 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 17
- 239000002775 capsule Substances 0.000 claims abstract description 14
- 239000012055 enteric layer Substances 0.000 claims abstract description 11
- 238000000034 method Methods 0.000 claims abstract description 5
- 239000000463 material Substances 0.000 claims abstract description 4
- 239000011248 coating agent Substances 0.000 claims description 15
- 238000000576 coating method Methods 0.000 claims description 15
- 238000001035 drying Methods 0.000 claims description 15
- 239000011265 semifinished product Substances 0.000 claims description 15
- 239000000243 solution Substances 0.000 claims description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 9
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 9
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 9
- 239000002861 polymer material Substances 0.000 claims description 9
- 239000007864 aqueous solution Substances 0.000 claims description 6
- 229920000137 polyphosphoric acid Polymers 0.000 claims description 6
- 239000000843 powder Substances 0.000 claims description 6
- 239000000047 product Substances 0.000 claims description 6
- 238000005507 spraying Methods 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 3
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 3
- 230000001112 coagulating effect Effects 0.000 claims description 3
- 239000012153 distilled water Substances 0.000 claims description 3
- 238000000227 grinding Methods 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 3
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 3
- 239000000725 suspension Substances 0.000 claims description 3
- 230000004584 weight gain Effects 0.000 claims description 3
- 235000019786 weight gain Nutrition 0.000 claims description 3
- 210000002784 stomach Anatomy 0.000 abstract description 8
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract description 7
- 210000003800 pharynx Anatomy 0.000 abstract description 6
- 210000000214 mouth Anatomy 0.000 abstract description 5
- 210000003238 esophagus Anatomy 0.000 abstract description 4
- 239000003826 tablet Substances 0.000 abstract description 4
- 210000004400 mucous membrane Anatomy 0.000 abstract description 3
- 230000002378 acidificating effect Effects 0.000 abstract description 2
- 210000004211 gastric acid Anatomy 0.000 abstract description 2
- 230000007774 longterm Effects 0.000 abstract description 2
- 230000001050 lubricating effect Effects 0.000 abstract description 2
- 210000003296 saliva Anatomy 0.000 abstract description 2
- 238000002474 experimental method Methods 0.000 description 5
- SYTBZMRGLBWNTM-UHFFFAOYSA-N flurbiprofen Chemical compound FC1=CC(C(C(O)=O)C)=CC=C1C1=CC=CC=C1 SYTBZMRGLBWNTM-UHFFFAOYSA-N 0.000 description 3
- 229960002390 flurbiprofen Drugs 0.000 description 3
- 210000004051 gastric juice Anatomy 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 230000008673 vomiting Effects 0.000 description 2
- 206010000087 Abdominal pain upper Diseases 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000029087 digestion Effects 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012634 fragment Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 210000000697 sensory organ Anatomy 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Abstract
The invention relates to the technical field of drug sustained release, in particular to an accurate sustained release tablet and a preparation method thereof; the capsule comprises a capsule, an enteric layer and a sustained-release layer, wherein the weight ratio of the capsule to the enteric layer is 1:2: 9; wherein the capsule material is water-absorbing polysaccharide. After the water-absorbing polysaccharide enters the mouth, water in the saliva is absorbed and a layer of lubricating layer for wrapping the tablet is quickly formed, and the structure can not be effectively adsorbed with mucous membranes of the oral cavity, the throat and the esophagus, so that the water-absorbing polysaccharide can quickly enter the stomach when being taken; the water-absorbing polysaccharide can be dissolved by gastric acid in the stomach, but the enteric layer can not be dissolved in an acidic environment, so that the tablet can continuously enter the intestinal tract, the enteric layer is disintegrated in a slightly alkaline environment of the intestinal tract, and finally the sustained-release layer slowly releases the main drug in the long-term process of the intestinal tract.
Description
Technical Field
The invention relates to the technical field of drug sustained release, in particular to an accurate sustained release tablet and a preparation method thereof.
Background
The sustained release tablet is usually formed by the main drug and the sustained release skeleton supporting agent together, and the release speed of the main drug is controlled by the slow disintegration and peeling of the sustained release skeleton supporting agent after being taken. The defects of the prior art are as follows: 1. part of the main drugs have strong pungent smell or taste, while the sustained-release tablets usually begin to disintegrate and release at the moment of entry, and are easy to stimulate the sense organ, thereby affecting swallowing and even causing vomiting of patients; 2. some main medicines have strong stimulation effect on the stomach, and the release of the sustained-release tablet in the stomach inevitably causes discomfort of the stomach of a patient, even causes stomachache, vomiting and the like; 3. no matter what kind of preparation method is adopted, the existing sustained-release tablet has certain probability of sticking to the throat, namely when the sustained-release tablet is taken together with water, the water enters the stomach and the sustained-release tablet is stuck to the mucous membrane of the throat area or the esophagus.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a sustained-release tablet which can ensure that the main drug is accurately and slowly released in the intestinal tract and a preparation method thereof.
The technical scheme of the invention is as follows:
the precise sustained-release tablet comprises a capsule, an enteric-coated layer and a sustained-release layer, wherein the weight ratio of the capsule to the enteric-coated layer to the sustained-release layer is 1:2: 9;
wherein the capsule material is water-absorbing polysaccharide.
Specifically, the enteric layer is made of Opadry.
Specifically, the sustained-release layer is a mixture of a main drug and an HPMC high polymer material, and the weight ratio of the main drug to the HPMC high polymer material is 1: 1.
The preparation method of the accurate sustained-release tablet comprises the following steps:
step one, uniformly mixing a main drug and an HPMC high polymer material, sieving the mixture by a 60-mesh sieve, and tabletting the mixture into a sustained-release layer;
placing the slow release layer into a fluidized bed coating pan for drying for ten minutes, weighing the Opadry coating premix according to the weight gain of 2/9, adding water to prepare a 7% solution, treating for 3 cycles by using a homogenizer, starting the fluidized bed, spraying until coating is finished, and drying to obtain a semi-finished product;
and step three, putting the semi-finished product into another coating pot, weighing the water-absorbing polysaccharide according to the weight increase 1/11, adding water to prepare 15% suspension, treating for 3 cycles by using a homogenizer, starting a fluidized bed, spraying until coating is finished, and drying to obtain the finished product.
Further, the preparation method of the water-absorbing polysaccharide comprises the following steps:
s1 dissolving 9 parts by weight of polyphosphoric acid in distilled water and adjusting pH to 11.5 with sodium hydroxide;
s2, uniformly putting 100 parts by weight of sodium carboxymethylcellulose into the solution, and coagulating the solution into gel;
s3, crushing the gel;
s4 drying the crushed gel at 120 deg.C for 150 min, and grinding with a grinder to 500 μm particle size to obtain semi-finished product;
s5 mixing 6 parts by weight of polyphosphoric acid with 100 parts by weight of water and adjusting pH to 11.0 as an aqueous solution;
s6, mixing 1 part by weight of semi-finished product with 10 parts by weight of aqueous solution, and drying the semi-finished product into powder by using a dry powder machine to obtain the finished product.
The invention has the beneficial effects that: after the water-absorbing polysaccharide enters the mouth, water in the saliva is absorbed and a layer of lubricating layer for wrapping the tablet is quickly formed, and the structure can not be effectively adsorbed with mucous membranes of the oral cavity, the throat and the esophagus, so that the water-absorbing polysaccharide can quickly enter the stomach when being taken; the water-absorbing polysaccharide can be dissolved by gastric acid in the stomach, but the enteric layer can not be dissolved in an acidic environment, so that the tablet can continuously enter the intestinal tract, the enteric layer is disintegrated in a slightly alkaline environment of the intestinal tract, and finally the sustained-release layer slowly releases the main drug in the long-term process of the intestinal tract.
Detailed Description
The following is further described in conjunction with the detailed description:
the precise sustained-release tablet comprises a capsule, an enteric-coated layer and a sustained-release layer, wherein the weight ratio of the capsule to the enteric-coated layer to the sustained-release layer is 1:2: 9;
wherein the capsule material is water-absorbing polysaccharide.
Specifically, the enteric layer is made of Opadry.
Specifically, the sustained-release layer is a mixture of a main drug and an HPMC high polymer material, and the weight ratio of the main drug to the HPMC high polymer material is 1: 1.
The preparation method of the accurate sustained-release tablet comprises the following steps:
step one, uniformly mixing a main drug and an HPMC high polymer material, sieving the mixture by a 60-mesh sieve, and tabletting the mixture into a sustained-release layer;
placing the slow release layer into a fluidized bed coating pan for drying for ten minutes, weighing the Opadry coating premix according to the weight gain of 2/9, adding water to prepare a 7% solution, treating for 3 cycles by using a homogenizer, starting the fluidized bed, spraying until coating is finished, and drying to obtain a semi-finished product;
and step three, putting the semi-finished product into another coating pot, weighing the water-absorbing polysaccharide according to the weight increase 1/11, adding water to prepare 15% suspension, treating for 3 cycles by using a homogenizer, starting a fluidized bed, spraying until coating is finished, and drying to obtain the finished product.
Further, the preparation method of the water-absorbing polysaccharide comprises the following steps:
s1 dissolving 9 parts by weight of polyphosphoric acid in distilled water and adjusting pH to 11.5 with sodium hydroxide;
s2, uniformly putting 100 parts by weight of sodium carboxymethylcellulose into the solution, and coagulating the solution into gel;
s3, crushing the gel;
s4 drying the crushed gel at 120 deg.C for 150 min, and grinding with a grinder to 500 μm particle size to obtain semi-finished product;
s5 mixing 6 parts by weight of polyphosphoric acid with 100 parts by weight of water and adjusting pH to 11.0 as an aqueous solution;
s6, mixing 1 part by weight of semi-finished product with 10 parts by weight of aqueous solution, and drying the semi-finished product into powder by using a dry powder machine to obtain the finished product.
The swallow experiment was carried out on the sustained release tablets obtained by the present invention and the commercial sustained release tablets (shanghai, zhongxi, three-dimensional pharmaceutical industry, ltd., flurbiprofen sustained release tablets):
200 volunteers were invited to divide into two groups (group a taking sustained release tablets are flurbiprofen sustained release tablets, group b taking sustained release tablets obtained by the present invention, two sustained release tablets are equal in weight) for experiment, the experiment content was to swallow the sustained release tablets once a day (the swallowed sustained release tablets are flurbiprofen sustained release tablets or sustained release tablets obtained by the present invention according to different groups), the administration was carried out for 9 days totally, and then whether the throat-sticking phenomenon (sticking to the oral cavity, throat or esophagus was counted) occurred was recorded.
The statistical results are as follows:
| group of | Frequency of throat sticking |
| a | 19 |
| b | 0 |
According to experiments, the invention combines the water-absorbing polysaccharide on the sustained-release tablet to reduce the occurrence of throat-sticking phenomenon.
Experiment of digestive ability of gastric juice on water-absorbing polysaccharide:
the water-absorbing polysaccharide was subjected to simulated digestion in a gastric juice simulated liquid (1 mol per ml hydrochloric acid solution +1 g per 100 ml pepsin).
Firstly, putting 1 g of water-absorbing polysaccharide film into 20 g of clear water;
and secondly, putting the imbibed water-absorbing polysaccharide film into 250 ml of gastric juice simulation liquid, and starting timing until the film is disintegrated into fragments with the area less than 10% of the original area.
And (3) timing results: for 5 seconds.
The foregoing embodiments and description have been presented only to illustrate the principles and preferred embodiments of the invention, and various changes and modifications may be made therein without departing from the spirit and scope of the invention as hereinafter claimed.
Claims (5)
1. Accurate sustained-release tablet, its characterized in that: the capsule comprises a capsule, an enteric layer and a sustained-release layer, wherein the weight ratio of the capsule to the enteric layer is 1:2: 9;
wherein the capsule material is water-absorbing polysaccharide.
2. The precision sustained-release tablet according to claim 1, wherein: the enteric layer is made of Opadry.
3. The precision sustained-release tablet according to claim 2, wherein: the sustained-release layer is a mixture of a main drug and HPMC high polymer material, and the weight ratio of the main drug to the HPMC high polymer material is 1: 1.
4. The preparation method of the accurate sustained-release tablet is characterized by comprising the following steps: it comprises the following steps:
step one, uniformly mixing a main drug and an HPMC high polymer material, sieving the mixture by a 60-mesh sieve, and tabletting the mixture into a sustained-release layer;
placing the slow release layer into a fluidized bed coating pan for drying for ten minutes, weighing the Opadry coating premix according to the weight gain of 2/9, adding water to prepare a 7% solution, treating for 3 cycles by using a homogenizer, starting the fluidized bed, spraying until coating is finished, and drying to obtain a semi-finished product;
and step three, putting the semi-finished product into another coating pot, weighing the water-absorbing polysaccharide according to the weight increase 1/11, adding water to prepare 15% suspension, treating for 3 cycles by using a homogenizer, starting a fluidized bed, spraying until coating is finished, and drying to obtain the finished product.
5. The method for preparing the precise sustained-release tablet according to claim 4, wherein the method comprises the following steps: the method comprises the following steps:
s1 dissolving 9 parts by weight of polyphosphoric acid in distilled water and adjusting pH to 11.5 with sodium hydroxide;
s2, uniformly putting 100 parts by weight of sodium carboxymethylcellulose into the solution, and coagulating the solution into gel;
s3, crushing the gel;
s4 drying the crushed gel at 120 deg.C for 150 min, and grinding with a grinder to 500 μm particle size to obtain semi-finished product;
s5 mixing 6 parts by weight of polyphosphoric acid with 100 parts by weight of water and adjusting pH to 11.0 as an aqueous solution;
s6, mixing 1 part by weight of semi-finished product with 10 parts by weight of aqueous solution, and drying the semi-finished product into powder by using a dry powder machine to obtain the finished product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011452650.1A CN112494443A (en) | 2020-12-12 | 2020-12-12 | Accurate sustained-release tablet and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011452650.1A CN112494443A (en) | 2020-12-12 | 2020-12-12 | Accurate sustained-release tablet and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112494443A true CN112494443A (en) | 2021-03-16 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202011452650.1A Pending CN112494443A (en) | 2020-12-12 | 2020-12-12 | Accurate sustained-release tablet and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN112494443A (en) |
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|---|---|---|---|---|
| JPH09124480A (en) * | 1995-10-27 | 1997-05-13 | Takeda Chem Ind Ltd | Vitamin preparation |
| CN1251035A (en) * | 1997-03-25 | 2000-04-19 | 武田药品工业株式会社 | Gastrointestinal mucosa-adherent pharmaceutical composition |
| US20040126330A1 (en) * | 2001-09-25 | 2004-07-01 | Tsutomu Awamura | Nicotine-containing film preparation |
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-
2020
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Application publication date: 20210316 |