CN111228231A - Preparation method of potassium chloride sustained-release tablet - Google Patents
Preparation method of potassium chloride sustained-release tablet Download PDFInfo
- Publication number
- CN111228231A CN111228231A CN202010114050.8A CN202010114050A CN111228231A CN 111228231 A CN111228231 A CN 111228231A CN 202010114050 A CN202010114050 A CN 202010114050A CN 111228231 A CN111228231 A CN 111228231A
- Authority
- CN
- China
- Prior art keywords
- potassium chloride
- crushed
- cottonseed oil
- sustained
- silicon dioxide
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Botany (AREA)
- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the technical field of biological medicines, and particularly relates to a preparation method of a potassium chloride sustained-release tablet, which comprises the following raw and auxiliary materials of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate: the potassium chloride and the hydrogenated cottonseed oil are crushed, mixed, sieved, mixed again, extruded by hot melting, granulated while hot, added with colloidal silicon dioxide and magnesium stearate after granulation, mixed completely and tabletted to obtain the sustained-release tablet. Research shows that the slow release tablet prepared by the process method still meets the requirement of quality standard after stability test.
Description
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to a preparation method of a potassium chloride sustained-release tablet.
Background
The potassium chloride is a clinically common electrolyte balance regulating medicament, is available in the early market and has definite clinical curative effect. Because potassium chloride has irritation to gastrointestinal tract, can cause nausea, vomit and inappetence, can cause gastric ulcer and duodenal ulcer, and common oral preparations are easy to cause peak-valley fluctuation to generate obvious adverse reactions, the sustained-release preparation is developed and marketed by people. The potassium chloride sustained release preparation can slowly and uniformly release the medicine in the gastrointestinal tract, has stable blood concentration, stable blood potassium and long action time, effectively reduces the irritation of the gastrointestinal tract and the adverse reaction, and is a more ideal medicinal potassium supplement preparation.
Potassium chloride belongs to water-soluble components, and the sustained-release tablets prepared from the potassium chloride have good clinical advantages, and a hot-melt extrusion process method is mostly adopted in the prior art, but the whole process research is not deeply researched, so that the potassium chloride sustained-release tablets have important significance in deep process research.
Disclosure of Invention
For the reasons, the applicant finds out through research that a novel preparation method of the potassium chloride sustained-release tablet is obtained, and the preparation method comprises the following steps: the potassium chloride and the hydrogenated cottonseed oil are crushed, mixed, sieved, mixed again, extruded by hot melting, granulated while hot, added with colloidal silicon dioxide and magnesium stearate after granulation, mixed completely and tabletted to obtain the sustained-release tablet. Research shows that the slow release tablet prepared by the process method still meets the requirement of quality standard after stability test.
The invention is realized by the following technical scheme.
A preparation method of a chlorinating agent sustained release tablet is characterized in that the preparation method comprises the following steps: the potassium chloride and the hydrogenated cottonseed oil are crushed, mixed, sieved, mixed again, extruded by hot melting, granulated while hot, added with colloidal silicon dioxide and magnesium stearate after granulation, mixed completely and tabletted to obtain the sustained-release tablet.
The preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55 ℃ plus or minus 2-62 ℃ plus or minus 2-53 ℃ plus or minus 2 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; finishing the extruded particles while the extruded particles are hot to obtain particles I;
(4) and (4) finishing the granules I obtained in the step (3) to obtain granules II, completely mixing the granules II with the crushed colloidal silicon dioxide and the crushed magnesium stearate, and tabletting to obtain the sustained-release tablets.
Wherein the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 450-550: 150-160: 3-4: 6-7.
Wherein the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
wherein the hot granule finishing process in the step (3) comprises the following steps: the extruded granules were placed in a granulator with a screen of 4X 4mm, square holes, 600rpm to give granules I. .
Wherein the whole grain process in the step (4) comprises the following steps: the granules I were placed in a pulverizer at a feed rate of 2.5s/T at 1000rpm with a 2mm screen to give granules II.
Detailed Description
The technical solutions of the present invention are described below with specific examples, but the scope of the present invention is not limited thereto.
The embodiments described in this specification are merely illustrative of implementations of the inventive concept and the scope of the present invention should not be considered limited to the specific forms set forth in the embodiments but rather by the equivalents thereof as may occur to those skilled in the art upon consideration of the present inventive concept. While the following embodiments of the invention have been described, the invention is not limited to the specific embodiments and applications described above, which are intended to be illustrative, instructive, and not limiting. Those skilled in the art, having the benefit of this disclosure, may effect numerous modifications thereto without departing from the scope of the invention as defined by the appended claims.
The following tests are conclusion tests of research personnel based on multiple creative tests and on the technical scheme to be protected by the invention.
Preparation examples
Example 1
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
53-60-51 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Example 2
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55-62-53 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Example 3
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
57-64-55 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Comparative example 1
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing: taking crushed hydrogenated cottonseed oil and crushed potassium chloride, putting the crushed hydrogenated cottonseed oil and the crushed potassium chloride into a mixer, and mixing for 15 minutes at the rotating speed of 15rpm to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55-62-53 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Comparative example 2
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55-62-53 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Comparative example 3
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55-63-60 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) granulating the granules I obtained in the step (3): and (3) putting the granules I into a grinder, feeding at 2.5s/T at 1000rpm, and screening by a 2mm screen to obtain granules II, completely mixing the granules II with the ground colloidal silicon dioxide and the ground magnesium stearate, and tabletting to obtain the sustained-release tablets.
Comparative example 4
The preparation comprises the following raw and auxiliary materials: the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is as follows: 500: 156: 3.3: 6.7.
the preparation method of the sustained-release tablet comprises the following steps:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55-62-53 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; granulating the extruded particles while the extruded particles are hot, putting the extruded particles into a granulator, and screening with a screen of 4 x 4mm and square holes at 600rpm to obtain particles I;
(4) and (4) completely mixing the granules I obtained in the step (3) with the crushed colloidal silicon dioxide and the crushed magnesium stearate, and tabletting to obtain the sustained-release tablet.
Coating the sustained-release tablets: the coating liquid is: film coating premix (gastric soluble form) (opadry II85F18422 WHITE): the weight ratio of the deionized water is as follows: 23.31: 116.55. packaging the coated aluminum plastic bubble cap.
Dissolution rate: taking different examples and comparative examples of sustained-release tablets, according to a dissolution and release rate determination method (a second method of 0931 of the general rules of pharmacopoeia on 2015 edition), taking 900ml of water as a dissolution medium, rotating at 50 revolutions per minute, operating according to the method, respectively taking 25ml of solution at 2 hours, 4 hours and 8 hours, filtering, immediately supplementing dissolution medium with the same temperature and volume, precisely taking 20ml of subsequent filtrate, adding 4 drops of potassium chromate indicating solution, titrating with silver nitrate titration solution (0.01mol/L) until the solution shows orange yellow, wherein each lml of silver nitrate titration solution (0.01mol/L) is equivalent to 0.7455mg of KC 1. The dissolution amount of each tablet of the product in 2 hours, 4 hours and 8 hours is respectively 5-65%, 50-85% and more than 85% of the marked amount. Original research imported preparation (FDA original research reagent potassium chloride sustained release tablet (trade name)
) The dissolution rate is as follows: 2 h: 50 percent; 4 h: 66 percent; 8 h: 86 percent.
And (3) stability test: taking the packaged potassium chloride sustained-release tablets (packaged by aluminum plastic after coating), and placing for 6 months at the temperature of 40 +/-2 ℃ and the relative humidity of 75% +/-5%. Samples were taken at the end of 1 month, 2 months, 3 months and 6 months of the test period, and the dissolution rates of the different formulations were determined, and the test results are shown in tables 1-4.
TABLE 11 dissolution of the formulations in months
TABLE 22 dissolution of the formulations in months
TABLE 33 dissolution of the month preparation
TABLE 46 dissolution of the formulations in months
And (4) test conclusion: (1) the mixing step of the raw materials and the auxiliary materials is changed (comparative example 1), the hot granule finishing step is removed (comparative example 2), the barrel temperature in the extrusion process is changed (comparative example 3), the granule finishing process step after the hot granule finishing is removed (comparative example 4), and the dissolution rate of the sustained release tablet obtained by the process method is unqualified after the stability test. (2) From the above comparative test results, it is shown that the process of the present invention is an organic whole, and the process parameters cannot be adjusted at will, but the process of the present invention can be obtained only by intensive research.
Claims (6)
1. A preparation method of a chlorinating agent sustained release tablet comprises the following raw and auxiliary materials of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate, and is characterized in that the preparation method comprises the following steps: the potassium chloride and the hydrogenated cottonseed oil are crushed, mixed, sieved, mixed again, extruded by hot melting, granulated while hot, added with colloidal silicon dioxide and magnesium stearate after granulation, mixed completely and tabletted to obtain the sustained-release tablet.
2. The method for preparing potassium chloride sustained-release tablets according to claim 1, wherein the method for preparing the sustained-release tablets comprises:
(1) crushing: taking potassium chloride, crushing, and screening by a 35-mesh screen to obtain crushed potassium chloride; crushing hydrogenated cottonseed oil, and sieving with a 35-mesh sieve to obtain crushed hydrogenated cottonseed oil; taking the colloidal silicon dioxide, crushing, and screening by a 35-mesh screen to obtain crushed colloidal silicon dioxide; taking magnesium stearate, crushing, and screening by a 35-mesh screen to obtain crushed magnesium stearate;
(2) mixing, sieving and remixing: adding the crushed hydrogenated cottonseed oil into a mixer, adding crushed potassium chloride with the same weight as the hydrogenated cottonseed oil, adjusting the rotating speed of the mixer to 10rpm, mixing for 5 minutes, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, adding the rest crushed potassium chloride, adjusting the rotating speed of the mixer to 15rpm, mixing for 5 minutes, sieving the mixture with a 14-mesh sieve, then placing the mixture into the mixer, adjusting the rotating speed of the mixer to 15rpm, and mixing for 15 minutes to obtain a mixture;
(3) adding the mixture obtained in the step (2) into a hot-melt extruder, wherein the screw speed is 500rpm, and the barrel temperature is as follows in sequence:
55 ℃ plus or minus 2-62 ℃ plus or minus 2-53 ℃ plus or minus 2 ℃; the blanking speed is 100kg/h, and no mouth mold exists; obtaining extruded particles; finishing the extruded particles while the extruded particles are hot to obtain particles I;
(4) and (4) finishing the granules I obtained in the step (3) to obtain granules II, completely mixing the granules II with the crushed colloidal silicon dioxide and the crushed magnesium stearate, and tabletting to obtain the sustained-release tablets.
3. The method for preparing a chlorinating agent sustained release tablet according to claim 1 or 2, wherein the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is: 450-550: 150-160: 3-4: 6-7.
4. The method for preparing a chlorinating agent sustained release tablet according to claim 1 or 2, wherein the weight ratio of potassium chloride, hydrogenated cottonseed oil, colloidal silicon dioxide and magnesium stearate is: 500: 156: 3.3: 6.7.
5. the method for preparing potassium chloride sustained-release tablets according to claim 2, wherein the hot granulation process of the extruded granules in the step (3) comprises: the extruded granules were placed in a granulator with a screen of 4X 4mm, square holes, 600rpm to give granules I.
6. The method for preparing potassium chloride sustained-release tablets according to claim 2, wherein the whole granulation process in the step (4) is as follows: the granules I were placed in a pulverizer at a feed rate of 2.5s/T at 1000rpm with a 2mm screen to give granules II.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010114050.8A CN111228231B (en) | 2020-02-24 | 2020-02-24 | Preparation method of potassium chloride sustained-release tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010114050.8A CN111228231B (en) | 2020-02-24 | 2020-02-24 | Preparation method of potassium chloride sustained-release tablet |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN111228231A true CN111228231A (en) | 2020-06-05 |
| CN111228231B CN111228231B (en) | 2022-11-01 |
Family
ID=70862200
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010114050.8A Active CN111228231B (en) | 2020-02-24 | 2020-02-24 | Preparation method of potassium chloride sustained-release tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111228231B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115554258A (en) * | 2022-10-09 | 2023-01-03 | 广州誉东健康制药有限公司 | Preparation equipment and preparation method of oral potassium chloride sustained-release tablet |
| CN116270512A (en) * | 2023-02-03 | 2023-06-23 | 天津力生制药股份有限公司 | Potassium chloride sustained release tablet and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2218905A (en) * | 1988-05-27 | 1989-11-29 | Elan Corp Plc | Controlled release potassium chloride tablet formulation |
| CN109125280A (en) * | 2018-10-28 | 2019-01-04 | 广州誉东健康制药有限公司 | A kind of potassium chloride sustained release preparation and preparation method thereof |
-
2020
- 2020-02-24 CN CN202010114050.8A patent/CN111228231B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2218905A (en) * | 1988-05-27 | 1989-11-29 | Elan Corp Plc | Controlled release potassium chloride tablet formulation |
| CN109125280A (en) * | 2018-10-28 | 2019-01-04 | 广州誉东健康制药有限公司 | A kind of potassium chloride sustained release preparation and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115554258A (en) * | 2022-10-09 | 2023-01-03 | 广州誉东健康制药有限公司 | Preparation equipment and preparation method of oral potassium chloride sustained-release tablet |
| CN116270512A (en) * | 2023-02-03 | 2023-06-23 | 天津力生制药股份有限公司 | Potassium chloride sustained release tablet and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN111228231B (en) | 2022-11-01 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| TW473393B (en) | Beta-lactam antibiotic-containing tablet and production thereof | |
| SU1577684A3 (en) | Method of obtaining tablets | |
| JP4334015B2 (en) | Aqueous granulation method for clarithromycin | |
| EP0095123B1 (en) | Sustained release diethylpropion compositions | |
| US5709886A (en) | Effervescent microcapsules | |
| CN111228231B (en) | Preparation method of potassium chloride sustained-release tablet | |
| RU2101009C1 (en) | Solid medicinal formula for oral use showing the delayed release of an active substance and a method of its making (variants) | |
| CN102961363B (en) | Potassium chloride slow release capsule | |
| CN105193763B (en) | A kind of hydrobromic acid Vortioxetine piece and preparation method thereof | |
| JP3368898B1 (en) | Process for producing granules containing branched chain amino acids | |
| CN104352441A (en) | DMF (dimethyl fumarate) enteric-coated micropellet and preparation method thereof | |
| CN111202716B (en) | Theophylline sustained release tablet and preparation method thereof | |
| EP2902015B1 (en) | Preparation method of agomelatine solid preparation | |
| CN109481412A (en) | A kind of II crystal linezolid piece and its preparation process | |
| CN111330012A (en) | Hydrogenated vegetable oil and application thereof | |
| CN112206213A (en) | Sildenafil citrate composition and preparation method thereof | |
| WO2002087602A1 (en) | Granulated product and process for producing tablets | |
| CN102526007A (en) | Florfenicol taste masking preparation and preparation method for same | |
| CN114288259B (en) | Quick-release preparation of vitamin B2 and preparation method thereof | |
| CN104606145B (en) | ibuprofen granule and preparation method thereof | |
| EP2915526A1 (en) | Pharmaceutical compositions comprising anagrelide | |
| JPH05105636A (en) | Antacid agent composition | |
| CN101940575B (en) | Cefditoren pivoxil solid preparation and preparation method thereof | |
| CN106580924B (en) | Multi-unit release pharmaceutical composition of amlodipine maleate and preparation method thereof | |
| JPH0558880A (en) | Masked granular substance |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |