CN112843021A - Process for preparing high-purity mesalazine enteric sustained-release preparation - Google Patents
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- CN112843021A CN112843021A CN202011418610.5A CN202011418610A CN112843021A CN 112843021 A CN112843021 A CN 112843021A CN 202011418610 A CN202011418610 A CN 202011418610A CN 112843021 A CN112843021 A CN 112843021A
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- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A—HUMAN NECESSITIES
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- 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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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
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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 provides a process for preparing a high-purity mesalazine enteric-coated sustained-release preparation, which comprises a capsule and a plurality of mesalazine enteric-coated sustained-release tablets hermetically contained in the capsule; the process comprises the following steps: preparing mesalazine enteric sustained-release tablets; preparing a capsule wrapping the mesalazine enteric-coated sustained-release tablet; and filling the mesalazine enteric-coated sustained-release tablets into the capsules to obtain a sustained-release preparation. The sustained-release tablet of the invention disperses the original single tablet into a plurality of tablets, and the tablets are uniformly accommodated by the capsule, so that the tablets can be dispersed in the intestinal tract after the capsule is disintegrated, and play a role of multi-point sustained release, thereby increasing the drug concentration at the affected part of the intestinal tract disease and being beneficial to the cure of the focus.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparation production, and particularly relates to a process for preparing a high-purity mesalazine enteric-coated sustained-release preparation.
Background
Mesalazine is an active ingredient of SASP for treating ulcerative colitis, and has a remarkable inhibition effect on inflammation of intestinal wall; mesalamine can inhibit the synthesis of prostaglandin causing inflammation and the formation of inflammatory mediator leukotriene, thereby playing a remarkable role in inhibiting the inflammation of intestinal mucosa, and mesalamine can inhibit the synthesis of prostaglandin in a dose-dependent manner and reduce the release of PGE2 in the colon mucosa of human.
At present, common mesalazine tablets are coated tablets, and an enteric coating is added on the outermost layer of the mesalazine tablets, so that the medicine cannot be disintegrated in gastric juice in advance after passing through the stomach of a patient, and effective ingredients can better act on intestinal mucosa. Although such tablets have a sustained-release disintegrating effect, the tablets are only disintegrated locally in the intestine, and it is difficult to ensure that an effective drug concentration is maintained at the affected part of the intestine.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: provides a process for preparing a high-purity mesalazine enteric sustained-release preparation, and realizes that the effective drug concentration can be ensured at the affected part of intestinal diseases by dispersing the traditional single-tablet preparation into a plurality of tablets.
The invention is realized by the following steps: a process for preparing a high-purity mesalazine enteric-coated sustained-release preparation, which comprises a capsule and a plurality of mesalazine enteric-coated sustained-release tablets hermetically contained in the capsule; the process comprises the following steps:
preparing mesalazine enteric sustained-release tablets;
preparing a capsule wrapping the mesalazine enteric-coated sustained-release tablet;
and filling the mesalazine enteric-coated sustained-release tablets into the capsules to obtain a sustained-release preparation.
Further, the process for preparing the mesalazine enteric sustained-release tablet comprises the following steps:
putting dextrin, citric acid and pure water into a stirring kettle, and stirring to obtain a mixed solution, wherein the stirring time is 40-60min, and the stirring speed is 100 plus 120 rad/min;
putting mesalazine, cellulose, starch and calcium carbonate into the stirring kettle, and stirring to obtain a soft material, wherein the stirring time is 30-40min, and the stirring speed is 80-100 rad/min;
the soft material is placed into an extruder to be extruded to obtain a bar I, the extrusion diameter is 7.8-8.2mm, the extrusion speed is 4-6cm/s, and the extrusion temperature is 70-80 ℃;
putting the bar I into a dryer to be dried to obtain a bar II, wherein the drying time is 30-40min, and the drying temperature is 60-68 ℃;
placing the second bar into a granulator to be granulated to obtain granules, wherein the length of the granules is 3-3.2 mm;
putting the granules into a tablet press to be pressed to obtain a sheet material, wherein the diameter of the tablet is 8.8-9.2mm, and the thickness of the tablet is 2.2-2.4 mm;
and (3) putting the tablet into an enteric coating machine for coating to obtain the mesalazine enteric sustained-release tablet.
Further, in the process of preparing the mesalamine enteric sustained-release tablet, by mass, 6.6 to 7 parts of dextrin, 10 to 16 parts of citric acid, 106 parts of pure water, 106 parts of mesalamine, 16 to 18 parts of cellulose, 18 to 20 parts of starch and 14 to 16 parts of calcium carbonate are included.
Further, in the process of preparing the mesalamine enteric sustained-release tablet, by mass, 6.8 parts of dextrin, 13 parts of citric acid, 103 parts of pure water, 110 parts of mesalamine, 17 parts of cellulose, 19 parts of starch and 15 parts of calcium carbonate.
Further, the process for preparing the capsule wrapping the mesalazine enteric-coated sustained-release tablet comprises the following steps:
putting hydroxypropyl cellulose, gelatinizer, coagulant aid and pure water into a stirrer, and stirring to obtain glue solution, wherein the stirring time is 60-80min, the stirring temperature is 40-50 ℃, and the stirring speed is 50-60 rad/min;
placing the glue solution into a defoaming machine for standing and defoaming to obtain a non-foaming glue solution, wherein the standing time is 2-3 h;
plasticizing the non-foam glue solution in a capsule mold to obtain a glue blank;
and cutting the rubber blank into a cutting machine to obtain a capsule body and a capsule cap.
Further, in the process of preparing the capsule wrapping the mesalazine enteric-coated sustained-release tablet, by mass, 96-98 parts of hydroxypropyl cellulose, 1.2-1.8 parts of gelling agent, 1-1.2 parts of coagulant aid and 220 parts of pure water.
Further, in the process of preparing the capsule wrapping the mesalazine enteric-coated sustained-release tablet, by mass, 97 parts of hydroxypropyl cellulose, 1.5 parts of gelling agent, 1.1 parts of coagulant aid and 210 parts of pure water are added.
Further, the process of filling the mesalazine enteric-coated sustained-release tablet into the capsule to obtain the sustained-release preparation comprises the following steps:
filling the mesalazine enteric sustained-release tablets into the capsule body of the capsule;
sleeving the capsule body and the capsule cap in a sleeving machine to obtain a sealing composition;
and (3) putting the sealing composition into an enteric coating machine for coating to obtain the sustained-release preparation.
The invention has the following beneficial effects: the sustained-release tablet of the invention disperses the original single tablet into a plurality of tablets, and the tablets are uniformly accommodated by the capsule, so that the tablets can be dispersed in the intestinal tract after the capsule is disintegrated, and play a role of multi-point sustained release, thereby increasing the drug concentration at the affected part of the intestinal tract disease and being beneficial to the cure of the focus.
Drawings
FIG. 1 is a schematic view showing the structure of a sustained-release preparation of the present invention;
FIG. 2 is a flow chart of a process for preparing the sustained-release formulation of the present invention.
Detailed Description
The invention is further described below with reference to the accompanying drawings. The following examples are only for illustrating the technical solutions of the present invention more clearly, and the protection scope of the present invention is not limited thereby.
Example one
As shown in fig. 1 and 2, a process for preparing a high-purity mesalazine enteric sustained-release preparation, which comprises a capsule 1 and a plurality of mesalazine enteric sustained-release tablets 2 hermetically contained in the capsule 1; the process comprises the following steps:
s1, preparing the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s11, placing 6.6 parts by mass of dextrin, 10 parts by mass of citric acid and 100 parts by mass of pure water into a stirring kettle, and stirring to obtain a mixed solution, wherein the stirring time is 40min, and the stirring speed is 100 rad/min.
S12, putting 106 parts by mass of mesalazine, 16 parts by mass of cellulose, 18 parts by mass of starch and 14 parts by mass of calcium carbonate into a stirring kettle, and stirring to obtain a soft material, wherein the stirring time is 30min, and the stirring speed is 80 rad/min.
S13, placing the soft material into an extruder to be extruded to obtain a bar I, wherein the extrusion diameter is 7.8mm, the extrusion speed is 4cm/S, and the extrusion temperature is 70 ℃.
S14, placing the bar I into a dryer to be dried to obtain a bar II, wherein the drying time is 30min, and the drying temperature is 60 ℃.
And S15, placing the second bar into a granulator to be granulated to obtain particles, wherein the length of the slices is 3 mm.
S16, putting the granules into a tablet press to be pressed into a sheet, wherein the diameter of the sheet is 8.8mm, and the thickness of the sheet is 2.2 mm.
S17, coating the tablet in an enteric coating machine to obtain the mesalazine enteric sustained-release tablet 2.
S2, preparing a capsule 1 wrapping the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s21, putting 96 parts by mass of hydroxypropyl cellulose, 1.2 parts by mass of gelling agent, 1 part by mass of coagulant aid and 200 parts by mass of pure water into a stirrer, and stirring for 60min at the stirring temperature of 40 ℃ at the stirring speed of 50rad/min to obtain a glue solution.
And S22, placing the glue solution into a defoaming machine, standing and defoaming to obtain a non-foaming glue solution, wherein the standing time is 2 hours.
And S23, plasticizing the non-foam glue solution in a capsule mould to obtain a glue blank.
And S24, cutting the rubber blank into the capsule body 101 and the capsule cap 102 after the rubber blank is placed into a cutting machine.
S3, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule 1 to obtain the sustained-release preparation. The specific process of the step is as follows:
s31, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule body 101 of the capsule 1.
And S32, sleeving the capsule body 101 and the capsule cap 102 in a sleeving machine to obtain the sealing composition.
S33, putting the sealing composition into an enteric coating machine for coating to obtain the sustained-release preparation.
Example two
A process for preparing high-purity mesalazine enteric sustained-release preparation, the high-purity mesalazine enteric sustained-release preparation comprises a capsule 1 and a plurality of mesalazine enteric sustained-release tablets 2 which are hermetically contained in the capsule 1; the process comprises the following steps:
s1, preparing the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s11, placing 7 parts by mass of dextrin, 16 parts by mass of citric acid and 106 parts by mass of pure water into a stirring kettle, and stirring to obtain a mixed solution, wherein the stirring time is 60min, and the stirring speed is 120 rad/min.
S12, putting 114 parts by mass of mesalazine, 18 parts by mass of cellulose, 20 parts by mass of starch and 16 parts by mass of calcium carbonate into a stirring kettle, and stirring to obtain a soft material, wherein the stirring time is 40min and the stirring speed is 100 rad/min.
S13, placing the soft material into an extruder to be extruded to obtain a bar I, wherein the extrusion diameter is 8.2mm, the extrusion speed is 6cm/S, and the extrusion temperature is 80 ℃.
S14, placing the bar I into a dryer to be dried to obtain a bar II, wherein the drying time is 40min, and the drying temperature is 68 ℃.
And S15, placing the second bar into a granulator to be granulated to obtain particles, wherein the length of the chips is 3.2 mm.
S16, putting the granules into a tablet press to be pressed into a sheet, wherein the diameter of the tablet is 9.2mm, and the thickness of the tablet is 2.4 mm.
S17, coating the tablet in an enteric coating machine to obtain the mesalazine enteric sustained-release tablet 2.
S2, preparing a capsule 1 wrapping the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s21, placing 98 parts by mass of hydroxypropyl cellulose, 1.8 parts by mass of gelling agent, 1.2 parts by mass of coagulant aid and 220 parts by mass of pure water into a stirrer, and stirring to obtain a glue solution, wherein the stirring time is 80min, the stirring temperature is 50 ℃, and the stirring speed is 60 rad/min.
And S22, placing the glue solution into a defoaming machine, standing and defoaming to obtain a non-foaming glue solution, wherein the standing time is 3 hours.
And S23, plasticizing the non-foam glue solution in a capsule mould to obtain a glue blank.
And S24, cutting the rubber blank into the capsule body 101 and the capsule cap 102 after the rubber blank is placed into a cutting machine.
S3, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule 1 to obtain the sustained-release preparation. The specific process of the step is as follows:
s31, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule body 101 of the capsule 1.
And S32, sleeving the capsule body 101 and the capsule cap 102 in a sleeving machine to obtain the sealing composition.
S33, putting the sealing composition into an enteric coating machine for coating to obtain the sustained-release preparation.
EXAMPLE III
A process for preparing high-purity mesalazine enteric sustained-release preparation, the high-purity mesalazine enteric sustained-release preparation comprises a capsule 1 and a plurality of mesalazine enteric sustained-release tablets 2 which are hermetically contained in the capsule 1; the process comprises the following steps:
s1, preparing the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s11, placing 6.8 parts by mass of dextrin, 13 parts by mass of citric acid and 103 parts by mass of pure water into a stirring kettle, and stirring to obtain a mixed solution, wherein the stirring time is 50min, and the stirring speed is 110 rad/min.
S12, placing 110 parts by mass of mesalazine, 17 parts by mass of cellulose, 19 parts by mass of starch and 15 parts by mass of calcium carbonate into a stirring kettle, and stirring to obtain a soft material, wherein the stirring time is 35min and the stirring speed is 90 rad/min.
S13, placing the soft material into an extruder to be extruded to obtain a bar I, wherein the extrusion diameter is 8mm, the extrusion speed is 5cm/S, and the extrusion temperature is 75 ℃.
S14, placing the bar I into a dryer to be dried to obtain a bar II, wherein the drying time is 35min, and the drying temperature is 64 ℃.
And S15, placing the second bar into a granulator to be granulated to obtain particles, wherein the length of the chips is 3.1 mm.
S16, putting the granules into a tablet press to be pressed into a sheet, wherein the diameter of the tablet is 9mm, and the thickness of the tablet is 2.3 mm.
S17, coating the tablet in an enteric coating machine to obtain the mesalazine enteric sustained-release tablet 2.
S2, preparing a capsule 1 wrapping the mesalazine enteric-coated sustained-release tablet 2. The specific process of the step is as follows:
s21, putting 97 parts by mass of hydroxypropyl cellulose, 1.5 parts by mass of gelling agent, 1.1 parts by mass of coagulant aid and 210 parts by mass of pure water into a stirrer, and stirring to obtain a glue solution, wherein the stirring time is 70min, the stirring temperature is 45 ℃, and the stirring speed is 55 rad/min.
And S22, placing the glue solution into a defoaming machine, standing and defoaming to obtain a non-foaming glue solution, wherein the standing time is 2.5 hours.
And S23, plasticizing the non-foam glue solution in a capsule mould to obtain a glue blank.
And S24, cutting the rubber blank into the capsule body 101 and the capsule cap 102 after the rubber blank is placed into a cutting machine.
S3, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule 1 to obtain the sustained-release preparation. The specific process of the step is as follows:
s31, filling the mesalazine enteric-coated sustained-release tablet 2 into the capsule body 101 of the capsule 1.
And S32, sleeving the capsule body 101 and the capsule cap 102 in a sleeving machine to obtain the sealing composition.
S33, putting the sealing composition into an enteric coating machine for coating to obtain the sustained-release preparation.
The above is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and variations can be made without departing from the technical principle of the present invention, and these modifications and variations should also be regarded as the protection scope of the present invention.
Claims (8)
1. A process for preparing a high-purity mesalazine enteric-coated sustained-release preparation is characterized in that the high-purity mesalazine enteric-coated sustained-release preparation comprises a capsule (1) and a plurality of mesalazine enteric-coated sustained-release tablets (2) which are hermetically contained in the capsule (1); the process comprises the following steps:
preparing mesalazine enteric sustained-release tablets (2);
preparing a capsule (1) wrapping the mesalazine enteric-coated sustained-release tablet (2);
filling the mesalazine enteric sustained-release tablet (2) into the capsule (1) to obtain a sustained-release preparation.
2. The process for preparing a high purity mesalazine enteric sustained release preparation according to claim 1, characterized in that the process for preparing the mesalazine enteric sustained release tablet (2) comprises the following steps:
putting dextrin, citric acid and pure water into a stirring kettle, and stirring to obtain a mixed solution, wherein the stirring time is 40-60min, and the stirring speed is 100 plus 120 rad/min;
putting mesalazine, cellulose, starch and calcium carbonate into the stirring kettle, and stirring to obtain a soft material, wherein the stirring time is 30-40min, and the stirring speed is 80-100 rad/min;
the soft material is placed into an extruder to be extruded to obtain a bar I, the extrusion diameter is 7.8-8.2mm, the extrusion speed is 4-6cm/s, and the extrusion temperature is 70-80 ℃;
putting the bar I into a dryer to be dried to obtain a bar II, wherein the drying time is 30-40min, and the drying temperature is 60-68 ℃;
placing the second bar into a granulator to be granulated to obtain granules, wherein the length of the granules is 3-3.2 mm;
putting the granules into a tablet press to be pressed to obtain a sheet material, wherein the diameter of the tablet is 8.8-9.2mm, and the thickness of the tablet is 2.2-2.4 mm;
and (3) putting the tablet into an enteric coating machine for coating to obtain the mesalazine enteric sustained-release tablet (2).
3. The process for preparing a high-purity mesalazine enteric-coated sustained-release preparation according to claim 2, wherein in the process of preparing the mesalazine enteric-coated sustained-release tablet (2), 6.6-7 parts by mass of dextrin, 10-16 parts by mass of citric acid, 106 parts by mass of pure water, 114 parts by mass of mesalazine, 16-18 parts by mass of cellulose, 18-20 parts by mass of starch and 14-16 parts by mass of calcium carbonate are used.
4. The process for preparing a high-purity mesalamine enteric sustained-release preparation according to claim 3, wherein 6.8 parts by mass of dextrin, 13 parts by mass of citric acid, 103 parts by mass of pure water, 110 parts by mass of mesalamine, 17 parts by mass of cellulose, 19 parts by mass of starch and 15 parts by mass of calcium carbonate are used in the process of preparing the mesalamine enteric sustained-release tablet (2).
5. The process for preparing a high purity mesalamine enteric sustained-release preparation according to claim 1, wherein the process of preparing the capsule (1) encapsulating the mesalamine enteric sustained-release tablet (2) comprises the following steps:
putting hydroxypropyl cellulose, gelatinizer, coagulant aid and pure water into a stirrer, and stirring to obtain glue solution, wherein the stirring time is 60-80min, the stirring temperature is 40-50 ℃, and the stirring speed is 50-60 rad/min;
placing the glue solution into a defoaming machine for standing and defoaming to obtain a non-foaming glue solution, wherein the standing time is 2-3 h;
plasticizing the non-foam glue solution in a capsule mold to obtain a glue blank;
and cutting the rubber blank into a capsule body (101) and a capsule cap (102) after the rubber blank is placed into a cutting machine.
6. The process for preparing a high-purity mesalamine enteric sustained-release preparation according to claim 5, wherein in the process of preparing the capsule (1) wrapping the mesalamine enteric sustained-release tablet (2), by mass, the hydroxypropyl cellulose accounts for 96-98 parts, the gelling agent accounts for 1.2-1.8 parts, the coagulant aid accounts for 1-1.2 parts, and the pure water accounts for 200-220 parts.
7. The process for preparing a high-purity mesalamine enteric sustained-release preparation according to claim 6, wherein in the process of preparing the capsule (1) encapsulating the mesalamine enteric sustained-release tablet (2), by mass, 97 parts of hydroxypropyl cellulose, 1.5 parts of gelling agent, 1.1 parts of coagulant aid and 210 parts of pure water are used.
8. The process for preparing a high-purity mesalamine enteric sustained-release preparation according to claim 1, wherein the process of filling the mesalamine enteric sustained-release tablet (2) in the capsule (1) to obtain the sustained-release preparation comprises the following steps:
filling the mesalazine enteric sustained-release tablet (2) into a capsule body (101) of the capsule (1);
putting the capsule body (101) and the capsule cap (102) into a sleeving machine to be sleeved to obtain a sealing composition;
and (3) putting the sealing composition into an enteric coating machine for coating to obtain the sustained-release preparation.
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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 |
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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 |
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