CN114748437A - Rebamipide gastric floating tablet and preparation method thereof - Google Patents
Rebamipide gastric floating tablet and preparation method thereof Download PDFInfo
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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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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Abstract
The invention discloses a rebamipide gastric floating tablet, which comprises the following raw materials in percentage by weight: 30-40% of rebamipide, 10-40% of framework material, 10-30% of swelling agent, 0-20% of bleaching aid, 0.5-10% of lubricant and 0-30% of diluent, and the tablet has short floating time, can continuously float for 10 hours, prolongs the retention time on the stomach and the upper end of the small intestine and correspondingly improves the bioavailability. The invention also relates to a preparation method of the rebamipide tablets, the preparation process is simple and feasible, and the prepared finished product has stable quality and is suitable for large-scale production.
Description
Technical Field
The invention relates to a tablet and a preparation method thereof, in particular to a rebamipide gastric floating tablet and a preparation method thereof.
Background
Studies have shown that ulcer disease or peptic ulcer is a common disease of the digestive tract, and can occur in the esophagus, stomach or duodenum, and also in the vicinity of the gastro-jejunostomy or in Meckel diverticula containing the gastric mucosa, and since gastric and duodenal ulcers are most common, the so-called peptic ulcers in general refer to gastric and duodenal ulcers. It is called peptic ulcer because it has been considered that gastric ulcer and duodenal ulcer are formed by the self-digestion of mucous membrane by gastric acid and pepsin, and in fact gastric acid and pepsin are only one of the main causes of ulcer formation, and there are other causes that can form peptic ulcer. With the acceleration of economic development of modern society and the enhancement of competitive consciousness of people, in order to save time, the factors of eating disorder, excessive fatigue, mental stress, smoking, alcoholism and the like of modern people are caused, so that the incidence rate of gastric ulcer is on an increasing trend year by year.
Rebamipide is a drug for the treatment of gastritis and gastric ulcer, synthesized and developed by tsukamur pharmaceutical companies, and marketed as a therapeutic agent for gastric ulcer in 1990 s 12 months. In addition, since the preparation has the effects of increasing endogenous Prostaglandin (PG) of gastric mucosa and inhibiting free radicals which are one of the pathogenesis factors of gastric mucosal injury, the research on the application range of the preparation to gastritis is expanded, and the function and the effect of the gastritis are increased in 6 months of 1994.
Rebamipide is a BCS IV drug, and has poor solubility and permeability, and the main absorption part of rebamipide is the upper end of the small intestine, particularly the stomach and duodenum, which causes the narrower absorption window and low bioavailability of rebamipide, and the conventional preparation of rebamipide needs to be taken three times a day to achieve better curative effect, and has poor patient compliance.
Patent CN109078186A discloses a rebamipide gastric-floating preparation, which uses a hot-melt extrusion process, has a complex preparation process, strict requirements on auxiliary materials and production processes, high production cost and difficulty in realizing industrial production, and has a dissolution curve which shows that the rebamipide gastric-floating preparation starts to be released within about 5 hours and has a long effect taking time.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to provide a rebamipide gastric-floating tablet, which is used for improving the bioavailability of rebamipide and reducing the medicine taking times of patients and has good compliance. The invention also aims to provide a preparation method of the rebamipide gastric-floating tablet, which is simple in process, stable in finished product quality and suitable for large-scale production.
The technical scheme is as follows: the rebamipide gastric-floating tablet provided by the invention comprises the following raw materials in percentage by weight: 30-40% of rebamipide, 10-40% of framework material, 10-30% of swelling agent, 0-20% of bleaching aid, 0.5-10% of lubricant and 0-30% of diluent.
The rebamipide gastric-floating tablet is characterized in that the skeleton material is one or more selected from hydroxypropyl methyl cellulose K100M, hydroxypropyl methyl cellulose K100LV, carbomer 934P and carbomer 971.
The swelling agent is crosslinked polyvinylpyrrolidone.
The bleaching assistant is cetyl alcohol.
The lubricant is magnesium stearate.
The diluent is microcrystalline cellulose 102.
Good flotation performance can be obtained without a gas generating agent.
The preparation method of the rebamipide gastric-floating tablet comprises the following steps:
(1) fully mixing rebamipide with other components except the lubricant;
(2) sieving the mixture obtained in the step (1);
(3) fully mixing a lubricant with the mixture obtained in the step (2);
(4) and (4) tabletting the mixture obtained in the step (3).
Wherein the hardness of the pressed sheet in the step (4) is 60N-70N. In step (2), the mixture is preferably sieved by a 30-mesh sieve.
Has the advantages that: the rebamipide gastric floating tablet provided by the invention can obtain good floating performance without a gas generating agent, has short floating time and quick response time, can continuously float for more than 10 hours in gastric juice, increases the contact time of a medicament and a focus, prolongs the retention time on the stomach and the upper end of small intestine, thereby improving the bioavailability and achieving better treatment effect. The rebamipide gastric-floating tablet prepared by the invention can be released continuously for a long time, the dosage interval is increased, and the compliance of patients is improved. The preparation method provided by the invention adopts powder direct pressing, the process is simple and easy to implement, and the prepared finished product has stable quality and is suitable for large-scale production.
Drawings
FIG. 1 is a release profile of the gastric floating tablet of rebamipide of example 1;
FIG. 2 is a release profile of the gastric floating tablet of rebamipide of example 2;
FIG. 3 is the release profile of the gastric floating tablet of rebamipide of example 3;
FIG. 4 is the release profile of the gastric floating tablet of rebamipide of example 4;
FIG. 5 is a release profile of the gastric floating tablet of rebamipide of example 5;
FIG. 6 is the release profile of the gastric floating tablet of rebamipide of example 6;
FIG. 7 is the release profile of the gastric floating tablet of rebamipide of example 7;
fig. 8 is a release profile of the gastric floating tablet of rebamipide of example 8.
Detailed Description
The technical solutions in the examples of the present invention will be described in detail below, but the embodiments of the present invention are not limited thereto. Unless otherwise indicated, reagents, materials and equipment used in the following examples are all available by conventional commercial means.
Example 1
| Composition (I) | Content (mg)/each tablet | Percent (%) content/ |
| Rebamipide | ||
| 100 | 37.74％ | |
| Microcrystalline cellulose 102 | 48 | 18.11％ |
| Hydroxypropyl methylcellulose K100M | 75 | 28.30％ |
| |
40 | 15.09％ |
| |
2 | 0.75％ |
The preparation process comprises the following steps:
(1) weighing rebamipide and each auxiliary material according to the proportion of the prescription;
(2) fully mixing rebamipide with all auxiliary materials except magnesium stearate;
(3) sieving the mixture obtained in the step (2) by a 30-mesh sieve;
(4) mixing the mixture sieved in the step (3) with magnesium stearate;
(5) and (4) directly tabletting the mixed powder obtained in the step (4), and controlling the hardness to be 60N-70N.
Method for measuring release:
according to the first method of appendix XD of 2020 annual edition of Chinese pharmacopoeia, the rebamipide gastric floating tablet is placed in a rotating basket, 900mL of degassed phosphate buffer solution with the pH value of 6.0 is taken as a release medium, the rotating speed is 100rpm, the temperature is (37 +/-0.5) DEG C, 10mL of the release medium is taken at 1h, 2h, 4h, 6h, 8h and 12h respectively, meanwhile, the same amount of the same-temperature fresh medium is supplemented, the mixture is filtered by a 0.45 mu m microporous membrane, 20 mu L of subsequent filtrate is taken and injected into a high performance liquid chromatograph, and the peak area of the subsequent filtrate is measured at 326 nm; in addition, a proper amount of reference substance is precisely weighed, the cumulative release percentage is calculated by the same method, and the requirement is met.
The release rate of the rebamipide gastric-floating tablet in example 1 is shown in fig. 1. Has good slow release effect.
The floating behavior determination method comprises the following steps:
the floating behavior was examined using a dissolution apparatus, paddle method, with 75rpm speed, 37. + -. 0.5 ℃ temperature, 900ml of 0.1M HCl medium. The tablet was placed in the dissolution cup for a timed start, the tablet state was observed and the time to float and the time to sink was recorded. 6 slices were measured and averaged.
The time to rise of the rebamipide gastric-floating tablet in example 1 was 10 minutes, and the floating time was 15 hours.
Example 2
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 2 is shown in fig. 2. Has good slow release effect.
The rebamipide gastric-floating tablet in example 2 had a floating time of 2 minutes and a floating duration of 10 hours.
Example 3
| Composition (A) | Content (mg)/each tablet | Percent (%) content/ |
| Rebamipide | ||
| 100 | 37.74％ | |
| Microcrystalline cellulose 102 | 48 | 18.11％ |
| Hydroxypropyl methylcellulose K100M | 37.5 | 14.15％ |
| Carbomer 971 | 37.5 | 14.15 |
| Crosslinked polyvinylpyrrolidone | ||
| 40 | 15.09 | |
| Magnesium stearate | ||
| 2 | 0.75％ |
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 3 is shown in fig. 3. Has good slow release effect.
The rebamipide gastric-floating tablet in example 3 had a floating time of 5 minutes and a floating duration of 12 hours.
Example 4
The preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as those in example 1.
The release rate of the rebamipide gastric-floating tablet in example 4 is shown in fig. 4. Has good slow release effect.
The time to rise of the rebamipide gastric-floating tablet in example 4 was 7 minutes, and the floating time was 16 hours.
Example 5
| Composition (I) | Content (mg)/each tablet | Percent (%) content/ |
| Rebamipide | ||
| 100 | 37.74％ | |
| Microcrystalline cellulose 102 | 48 | 18.11％ |
| Hydroxypropyl methylcellulose K100LV | 75 | 28.30 |
| Crosslinked polyvinylpyrrolidone | ||
| 40 | 15.09 | |
| Magnesium stearate | ||
| 2 | 0.75％ |
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 5 is shown in fig. 5. Has good slow release effect.
The rebamipide gastric-floating tablet in example 5 had a floating time of 0 minute and a floating duration of 15 hours.
Example 6
| Composition (I) | Content (mg)/each tablet | Percent (%) content/ |
| Rebamipide | ||
| 100 | 37.74％ | |
| Hydroxypropyl methylcellulose K100LV | 50 | 18.87％ |
| Carbomer 971 | 25 | 9.43 |
| Crosslinked polyvinylpyrrolidone | ||
| 40 | 15.09％ | |
| Cetyl alcohol | 48 | 18.11 |
| Magnesium stearate | ||
| 2 | 0.75％ |
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 6 is shown in fig. 6. Has good slow release effect.
The time to rise of the rebamipide gastric-floating tablet in example 6 was 9 minutes, and the floating time was 12 hours.
Example 7
| Composition (I) | Content (mg)/each tablet | Percent (%) content/ |
| Rebamipide | ||
| 100 | 37.74％ | |
| Microcrystalline cellulose 102 | 23 | 8.68％ |
| Hydroxypropyl methylcellulose K100LV | 50 | 18.87％ |
| Carbomer 971 | 25 | 9.43 |
| Crosslinked polyvinylpyrrolidone | ||
| 40 | 15.09％ | |
| Cetyl alcohol | 25 | 9.43 |
| Magnesium stearate | ||
| 2 | 0.75％ |
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 7 is shown in fig. 7. Has good slow release effect.
The rebamipide gastric-floating tablets in example 7 had a 3 minute rise time and a 10 hour duration of floating.
Example 8
| Composition (I) | Content (mg)/each tablet | Percent (%)/per |
| Rebamipide | ||
| 100 | 37.74％ | |
| Microcrystalline cellulose 102 | 23 | 8.68％ |
| Hydroxypropyl methylcellulose K100LV | 50 | 18.87％ |
| Carbomer 934P | 25 | 9.43 |
| Crosslinked polyvinylpyrrolidone | ||
| 40 | 15.09％ | |
| Cetyl alcohol | 25 | 9.43 |
| Magnesium stearate | ||
| 2 | 0.75％ |
The specific preparation process, the method for measuring the release degree and the method for measuring the floating behavior are the same as in example 1.
The release rate of the rebamipide gastric-floating tablet in example 8 is shown in fig. 8. Has good slow release effect.
The rebamipide gastric-floating tablet in example 8 had a 3-minute rising time and a 10-hour duration of floating time.
The floating time of example 7 was 3 minutes and 10 hours, and the gastric-floating tablet obtained in example 7 was subjected to a high-temperature test (60 ℃ C.) and a high-intensity light irradiation test (4500 lx. + -. 500lx), respectively, to loft for 30 days, to detect the substance concerned. The results are shown in the following table:
the impurity structure is shown in the following table:
from the lofting result, the impurity content is not increased under the conditions of high temperature and illumination, and new impurities are not generated, so that the rebamipide gastric-floating tablet prepared by the invention has good stability and stable preparation process.
Claims (9)
1. The rebamipide gastric floating tablet is characterized by comprising the following raw materials in percentage by weight: 30-40% of rebamipide, 10-40% of framework material, 10-30% of swelling agent, 0-20% of bleaching aid, 0.5-10% of lubricant and 0-30% of diluent.
2. The rebamipide gastric-floating tablet according to claim 1, wherein the skeleton material is one or more selected from hydroxypropyl methylcellulose K100M, hydroxypropyl methylcellulose K100LV, carbomer 934P and carbomer 971.
3. The rebamipide gastric-floating tablet according to claim 1, wherein the swelling agent is cross-linked polyvinylpyrrolidone.
4. The rebamipide gastric-floating tablet according to claim 1, wherein the bleaching aid is cetyl alcohol.
5. The rebamipide floating gastric tablet according to claim 1, wherein the lubricant is magnesium stearate.
6. The rebamipide gastric-floating tablet according to claim 1, wherein the diluent is microcrystalline cellulose 102.
7. The rebamipide gastric-floating tablet according to claim 1, wherein good floating performance can be obtained without a gas generating agent.
8. A method for preparing rebamipide gastric-floating tablets according to claim 1, comprising the steps of:
(1) fully mixing rebamipide with other components except the lubricant;
(2) sieving the mixture obtained in the step (1);
(3) fully mixing a lubricant with the mixture obtained in the step (2);
(4) and (4) tabletting the mixture obtained in the step (3).
9. The production method according to claim 8, wherein the tablet hardness in the step (4) is 60N to 70N.
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2022
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