CN112494447A - Preparation process of mesalazine enteric-coated sustained-release tablet - Google Patents
Preparation process of mesalazine enteric-coated sustained-release tablet Download PDFInfo
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- CN112494447A CN112494447A CN202011540364.0A CN202011540364A CN112494447A CN 112494447 A CN112494447 A CN 112494447A CN 202011540364 A CN202011540364 A CN 202011540364A CN 112494447 A CN112494447 A CN 112494447A
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- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
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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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
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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
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
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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
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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 preparation process of a mesalazine enteric-coated sustained-release tablet, which comprises the following steps: preparation of the binder solution: mixing beta-cyclodextrin, chitosan and deionized water, magnetically stirring until the solution is uniform, adding disodium hydrogen phosphate, and stirring and mixing uniformly for later use; slowly adding mesalazine and an adhesive into a rapid wet mixing granulator under stirring, immediately adding a thickening agent after the adding, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; finally, the tablet is placed in a film coating machine, and the coating liquid is sprayed for enteric coating, so that the high-purity mesalazine enteric sustained-release tablet preparation is obtained. The preparation process is simple and suitable for industrial production.
Description
Technical Field
The invention belongs to the technical field of preparation of chemicals, and particularly relates to a preparation process of a mesalazine enteric-coated sustained-release tablet.
Background
Ulcerative Colitis (UC) is a chronic nonspecific intestinal inflammation whose etiology is not well-defined, and the diseased region is mainly in the mucous membrane and submucosa of the colon and rectum, and can form macroscopic erosion and ulcer. The lesions range from the distal colon, with reversible progression to the proximal, even affecting the entire colon, and occasionally affecting the terminal ileum, in a continuous distribution. The incidence rate of the UC is high in European and American areas, the incidence rate of the UC is relatively low in non-national countries, the number of cases reported in China is gradually increased in recent years, and the incidence rate of the UC in China is on an increasing trend. As the etiology and pathogenesis of the disease are not clarified, the treatment lacks specificity, so that the disease condition is delayed and repeated, even the disease becomes cancerous, the physical and mental health of a patient is seriously influenced, and the disease is listed as difficult disease by the world health organization.
Mesalamine (mesalamine) is also called 5-aminosalicylic acid (5-ASA) and is a first-line medicament for clinically treating mild-moderate UC at present due to definite curative effect. It exerts an anti-inflammatory effect by inhibiting the formation of prostaglandin E and leukotrienes, its action is local, i.e. it exerts an effect when contacting and complexing with the intestinal mucosa, its therapeutic effect is related to the concentration and duration of the drugs contacting the inflammatory intestinal mucosa, and is not much related to the blood drug concentration. The mesalazine can be absorbed by stomach and small intestine quickly by direct oral administration, can not reach colon to play an anti-inflammatory role, and meanwhile, the medicine inhaled into the body is easy to generate toxicity, so the mesalazine oral preparation must be designed into an enteric preparation to reduce the absorption in the upper gastrointestinal tract, so that the mesalazine oral preparation is positioned to the terminal ileum or colon to release the medicine, and the effective medicine concentration in the pathological intestinal section can be maintained.
The prior art also discloses a preparation method of the mesalazine enteric sustained-release tablet preparation, for example, the application numbers are as follows: the Chinese patent of CN201611115822.X discloses a preparation method of a mesalazine enteric-coated sustained-release tablet, which takes povidone as an adhesive, adopts wet granulation and tabletting processes to prepare a mesalazine sustained-release tablet core, and then prepares the enteric-coated sustained-release tablet through enteric coating, wherein each tablet contains 1.2g of mesalazine. As another example, application numbers are: CN201210318122.6, a chinese patent invention, discloses a mesalazine enteric coated tablet and a preparation method thereof, which are prepared by adopting a nanotechnology, an enteric coating technology and a pellet tabletting technology. The enteric-coated sustained-release tablets are prepared by an enteric-coated technology and a tabletting technology, other substances are added, and the obtained enteric-coated sustained-release tablets are used for conventional administration and are not obvious in improvement of treatment effect.
Disclosure of Invention
The invention mainly aims to provide a preparation process of a mesalazine enteric-coated sustained-release tablet aiming at the defects in the prior art. The preparation method is simple, the obtained mesalazine enteric-coated sustained-release tablet has good effect and no harm to human body, and no pollutant is generated in the preparation process, so that the mesalazine enteric-coated sustained-release tablet is an environment-friendly medicine.
The purpose of the invention and the technical problem to be solved are realized by adopting the following technical scheme.
The invention provides a preparation process of a mesalazine enteric-coated sustained-release tablet, which comprises the following steps:
preparation of the binder solution: mixing beta-cyclodextrin, chitosan and deionized water, magnetically stirring until the solution is uniform, adding disodium hydrogen phosphate, and stirring and mixing uniformly for later use;
slowly adding mesalazine and an adhesive into a rapid wet mixing granulator under stirring, immediately adding a thickening agent after the adding, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; finally, the tablet is placed in a film coating machine, and the coating liquid is sprayed for enteric coating, so that the high-purity mesalazine enteric sustained-release tablet preparation is obtained.
The preparation process of the mesalazine enteric-coated sustained-release tablet comprises the following steps of (1): (0.1-0.5).
The preparation process of the mesalazine enteric-coated sustained-release tablet comprises the following steps of (1): (0.02-0.05).
The preparation process of the mesalazine enteric-coated sustained-release tablet comprises the following steps of (1 g) beta-cyclodextrin and deionized water: (2-5) mL.
In the preparation process of the mesalazine enteric-coated sustained-release tablet, the thickener is any one selected from sodium alginate, carboxymethyl cellulose, guar gum, agar and hydroxypropyl methyl cellulose.
The preparation process of the mesalazine enteric-coated sustained-release tablet comprises the following steps of (0.1-0.4) by mass: 1.
the preparation process of the mesalazine enteric-coated sustained-release tablet comprises the following steps: 10 parts of coating material, 2 parts of plasticizer, 3 parts of surfactant and 135 parts of solvent.
In the preparation process of the mesalazine enteric-coated sustained-release tablet, the coating material is polyacrylic resin III; the plasticizer is polyethylene glycol; the surfactant is polysorbate 80; the solvent is ethanol or deionized water.
The preparation process of the mesalazine enteric-coated sustained-release tablet comprises the step of increasing the weight of the coating liquid to the tablet core by 1.0-2.5%.
By the technical scheme, the invention at least has the following advantages: the invention takes the mixed solution of beta-cyclodextrin and chitosan as the adhesive, on one hand, the adhesive effect is good, and on the other hand, the used raw materials are safe and nontoxic, thus being suitable for industrial production. The preparation method is simple, the used raw materials are simple in components, and the preparation is non-toxic and harmless to human bodies and environment-friendly.
The foregoing is a summary of the present invention, and in order to provide a clear understanding of the technical means of the present invention and to be implemented in accordance with the present specification, the following is a detailed description of the preferred embodiments of the present invention.
Detailed Description
In order to make the technical means, the creation features, the achievement purposes and the effects of the invention easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
Mixing 100 parts of beta-cyclodextrin, 30 parts of chitosan and 350 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, adding 4 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 200 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 15 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of ethanol) for enteric coating, wherein the weight of the coating liquid on the tablet core is increased by 1.5%, so that the mesalazine enteric sustained-release tablets are obtained.
Example 2
Mixing 100 parts of beta-cyclodextrin, 50 parts of chitosan and 350 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, then adding 2 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 150 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 15 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of ethanol) for enteric coating, wherein the weight of the coating liquid on the tablet core is increased by 1.5%, so that the mesalazine enteric sustained-release tablets are obtained.
Example 3
Mixing 100 parts of beta-cyclodextrin, 10 parts of chitosan and 200 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, then adding 5 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 150 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 5 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of deionized water) for enteric coating, wherein the weight of the coating liquid on the tablet cores is increased by 1.5%, so that the mesalazine enteric sustained-release tablets are obtained.
Example 4
Mixing 100 parts of beta-cyclodextrin, 20 parts of chitosan and 400 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, then adding 3 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 200 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 20 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of ethanol) for enteric coating, wherein the weight of the coating liquid on the tablet core is increased by 1.0%, so that the mesalazine enteric sustained-release tablets are obtained.
Example 5
Mixing 100 parts of beta-cyclodextrin, 40 parts of chitosan and 500 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, then adding 4 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 200 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 10 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of deionized water) for enteric coating, wherein the weight of the coating liquid on the tablet cores is increased by 2.0%, so that the mesalazine enteric sustained-release tablets are obtained.
Example 6
Mixing 100 parts of beta-cyclodextrin, 40 parts of chitosan and 500 parts of deionized water according to parts by weight, magnetically stirring until the solution is uniform, then adding 4 parts of disodium hydrogen phosphate, stirring and uniformly mixing to obtain the adhesive for later use. Slowly adding 50 parts of mesalazine and 200 parts of adhesive into a rapid wet mixing granulator under stirring, immediately adding 10 parts of sodium alginate, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; and finally, putting the tablets into a film coating machine, and spraying coating liquid (10 parts of polyacrylic resin III, 2 parts of polyethylene glycol, 803 parts of polysorbate and 135 parts of deionized water) for enteric coating, wherein the weight of the coating liquid on the tablet cores is increased by 2.0%, so that the mesalazine enteric sustained-release tablets are obtained.
Comparative example 1
The mesalazine enteric-coated tablet is sold on the market.
Test example 1 comparison of Release amounts in acid-neutralizing buffer solution for Mesalazine enteric-coated tablets
Sample preparation: the mesalamine enteric coated tablets obtained in example 1 and the mesalamine enteric coated tablets of comparative example 1.
The method comprises the following steps: the results are shown in table 1 and table 2, measured according to the release degree measurement method in the Chinese pharmacopoeia 2010 edition.
TABLE 1 comparison of the amount of acid released
| Sample (I) | Amount released in acid (% by weight) |
| Example 1 | 0.02～0.08 |
| Comparative example 1 | 1.2～3.5 |
TABLE 2 comparison of the amount released in the buffer
| Sample (I) | Release amount in buffer (% indicated) |
| Example 1 | Over 99.9 |
| Comparative example 1 | 94.2～98.3 |
As can be seen from the results in tables 1 and 2, the mesalamine enteric sustained-release tablets obtained by the method of the present invention have significantly reduced release amount in acid compared to commercially available mesalamine enteric sustained-release tablets; but the release amount is obviously higher than that of the buffer solution of the commercially available mesalazine enteric-coated tablet.
Test example 2 comparison of stability of Mesalazine enteric-coated tablets
Samples of the mesalamine enteric coated tablets prepared in example 1 of the present invention and the mesalamine preparation prepared in comparative example 1 were placed at 25 ℃ ± 2 ℃ and RH 60% ± 10% and sampled at the end of months 0, 12, 24, 36 and 48, and the release amount in acid, the release amount in buffer, the limit of impurities and the content were measured, and the results are shown in table 3.
TABLE 3 comparison of stability
| Sample (I) | Period of validity |
| Example 1 | No significant change in 48 months |
| Comparative example 1 | No significant change in 24 months |
The above results indicate that the mesalamine enteric coated tablet prepared in example 1 of the present invention has a significantly longer shelf life and increased stability than the mesalamine preparation of comparative example 2.
Test example 3 comparison of the drug efficacy of mesalazine enteric coated tablets
6 mice were selected and randomly divided into 2 groups, fasted for 12 hours, and the mesalamine enteric coated tablets prepared in inventive example 1 and the mesalamine preparation of comparative example 1 were administered with the same dose, each group of mice was sacrificed after 60 minutes, colon tissues were separated, cut into small pieces, homogenized in ice bath for 5 minutes, propionic anhydride was added, shaken for 10 minutes, methanol was added, shaken for 2 minutes, centrifuged, and the supernatant was taken, and the mesalamine concentration was measured with a high performance liquid chromatograph. The results are shown in Table 4.
TABLE 4 comparison of drug concentrations in colon tissue fluid of mice
| Sample (I) | Drug concentration (ug/mL) |
| Example 1 | 12.02±0.15 |
| Comparative example 1 | 5.22±0.23 |
The results show that the concentration of the drug in the colon tissue fluid of the mesalamine enteric-coated tablet prepared by the invention is obviously increased compared with the colon tissue fluid of the mesalamine enteric-coated preparation prepared by the prior art, so that the product prepared by the invention has better curative effect than the product prepared by the prior art.
Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (9)
1. A preparation process of mesalazine enteric sustained-release tablets is characterized by comprising the following steps:
preparation of the binder solution: mixing beta-cyclodextrin, chitosan and deionized water, magnetically stirring until the solution is uniform, adding disodium hydrogen phosphate, and stirring and mixing uniformly for later use;
slowly adding mesalazine and an adhesive into a rapid wet mixing granulator under stirring, immediately adding a thickening agent after the adding, and keeping stirring until a proper soft material is formed; the soft material is properly rounded after passing through an extruder, dried to obtain dry particles, and then the particles are tabletted through a double-layer tabletting machine to prepare tablets; finally, the tablet is placed in a film coating machine, and the coating liquid is sprayed for enteric coating, so that the high-purity mesalazine enteric sustained-release tablet preparation is obtained.
2. The preparation process of the mesalamine enteric sustained-release tablet according to claim 1, wherein the mass ratio of the beta-cyclodextrin to the chitosan is 1: (0.1-0.5).
3. The preparation process of the mesalamine enteric sustained-release tablet according to claim 1, wherein the mass ratio of the beta-cyclodextrin to the disodium hydrogen phosphate is 1: (0.02-0.05).
4. The process for preparing mesalamine enteric sustained-release tablets according to claim 1, wherein the ratio of beta-cyclodextrin to deionized water is 1 g: (2-5) mL.
5. The process for preparing mesalamine enteric sustained-release tablets according to claim 1, wherein the thickener is any one selected from sodium alginate, carboxymethyl cellulose, guar gum, agar and hydroxypropyl methyl cellulose.
6. The preparation process of the mesalamine enteric sustained-release tablet according to claim 1, wherein the mass ratio of the thickening agent to the mesalamine is (0.1-0.4): 1.
7. the process for preparing mesalazine enteric sustained-release tablets according to claim 1, wherein the coating solution comprises the following components: 10 parts of coating material, 2 parts of plasticizer, 3 parts of surfactant and 135 parts of solvent.
8. The process for preparing mesalamine enteric sustained-release tablets according to claim 7, wherein the coating material is polyacrylic resin III; the plasticizer is polyethylene glycol; the surfactant is polysorbate 80; the solvent is ethanol or deionized water.
9. The preparation process of the mesalamine enteric sustained-release tablet according to claim 7, wherein the weight of the coating solution to the tablet core is increased by 1.0-2.5%.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113855643A (en) * | 2021-11-10 | 2021-12-31 | 葵花药业集团佳木斯鹿灵制药有限公司 | Mesalazine sustained release preparation for colon-specific drug release and preparation process thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108159012A (en) * | 2016-12-07 | 2018-06-15 | 天津药物研究院有限公司 | A kind of preparation method of mesalazine enteric-coated sustained-release tablet |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108159012A (en) * | 2016-12-07 | 2018-06-15 | 天津药物研究院有限公司 | A kind of preparation method of mesalazine enteric-coated sustained-release tablet |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113855643A (en) * | 2021-11-10 | 2021-12-31 | 葵花药业集团佳木斯鹿灵制药有限公司 | Mesalazine sustained release preparation for colon-specific drug release and preparation process thereof |
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