Potassium chloride sustained-release pellet and preparation method and application thereof

A technology for slow-release pellets and potassium chloride pellets, which is applied to the active ingredients of alkaline/alkaline earth metal chlorides, pharmaceutical formulations, microcapsules, etc. Excellent water permeability, good release reproducibility, and cost-saving effects

Active Publication Date: 2018-03-23
杭州高成生物营养技术有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The CN102961363A process adopts the extrusion spheronization method, and the yield of pellets is low at one time. After drying and sieving, it needs to be extruded again, prolonging the time of the process, and it needs repeated extrusion to become a finished product, which does not meet the requirements of GMP
And CN102961363A technology, adopts ethanol to make solvent, has potential safety hazard, needs anti-riot facility, for serious air pollution, needs to have environmental protection measure
[0013] Sustained-release tablets of potassium chloride have been marketed in China, but due to the high water solubility of potassium chloride, it is often difficult to control the release of drugs well in existing sustained-release preparations, and burst release phenomenon often occurs, which has great potential Risks, such as localized high concentrations of cationic potassium in the GI system due to burst release, causing symptoms such as GI ulceration, bleeding, and perforation
In addition, the existing sustained-release tablets belong to a single unit system, and when gastrointestinal obstruction, esophageal stricture, diverticulum, and lack of intestinal tone further increase the stimulation of the gastrointestinal tract, which can aggravate the condition

Method used

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  • Potassium chloride sustained-release pellet and preparation method and application thereof
  • Potassium chloride sustained-release pellet and preparation method and application thereof
  • Potassium chloride sustained-release pellet and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Step 1: Making the pellet core:

[0063] In terms of weight percentage: take starch: 20%, sucrose: 70%, dextrin: 9%, and 30% syrup solution as binder.

[0064] a. The sucrose is crushed and processed into powder with less than 80 meshes, starch is added, and dextrin is uniformly mixed through a mixer to make a mixed powder of sugar, starch and dextrin.

[0065] b. Put the mixed powder in the coating granulator, and start the main machine of the coating granulator at 80r / min. Air pressure of blower: 0.03Kpa. The 30% syrup solution passes through a peristaltic pump at a speed of 50r / min, and is atomized and sprayed onto the rotating mixed powder through a spray gun to form sugar pills. Put the sugar pellets in a fluidized bed to boil and dry, control the inlet air temperature at 90-110 degrees, and dry for 30-40 minutes with a moisture content of ≤5%. After sieving, they will become sugar pellets with a target particle size of 0.2-0.4mm.

[0066] Step 2: Making the main medicin...

Embodiment 2

[0085] Step 1: Making the pellet core:

[0086] In terms of weight percentages: starch: 25%, sucrose: 65%, dextrin: 10%, and purified aqueous solution as a binder.

[0087] a. The sugar is crushed and processed into powder with less than 80 mesh.

[0088] b. Add starch, dextrin is mixed evenly through a mixer to make sugar, starch, dextrin mixed powder.

[0089] c. Put the mixed powder in the coating granulator to start the coating granulator with a speed of 70r / min. Air pressure of blower: 0.04Kpa. The purified water solution is atomized and sprayed into the rotating mixed powder through the spray gun through the peristaltic pump at a speed of 45r / min to form sugar pellets. The sugar pellets are placed in a fluidized bed to boil and dry, and the inlet air temperature is controlled to 90-110 degrees, and the drying is 35-40. Minutes, dried in a fluidized bed, moisture content ≤5%, and sieved to make it into a sugar pill with a target particle size of 0.2-0.4mm.

[0090] Step 2: Makin...

Embodiment 3

[0109] Step 1: Making the pellet core:

[0110] According to weight percentage: take starch: 20%, sugar: 70%, dextrin; 9%, 50% syrup solution as binder.

[0111] a. The sugar is crushed and processed into powder with less than 80 mesh, starch is added, and dextrin is mixed evenly through a mixer to make a mixed powder of sugar, starch and dextrin.

[0112] b. Put the mixed powder in the coating granulator to start the coating granulator host speed r / min50. Air pressure of blower: 0.02Kpa. The 30% syrup solution passes through the peristaltic pump at r / min: 75. The spray gun is atomized and sprayed onto the rotating mixed powder to form sugar pellets. Place the sugar pellets in a fluidized bed to boil and dry, control the inlet air temperature at 90-110 degrees, dry for 35-45 minutes, set the temperature in the fluidized bed to 100°C, moisture content ≤5%, and sieving to make it the target pellet The diameter is 0.2-0.4mm sugar pill.

[0113] Step 2: Making the main medicine layer:...

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Abstract

The invention relates to a potassium chloride sustained-release pellet and a preparation method and application thereof. The potassium chloride sustained-release pellet provided by the invention comprises a pellet core, a potassium chloride main drug layer, an isolated layer, a sustained-release coating layer and a colored coating layer. According to the potassium chloride sustained-release pelletprepared in the invention, the release amount within 1 hour is smaller than or equal to 25%, the release amount within 4 hours is smaller than or equal to 70%, and the release amount of the potassiumchloride sustained-release pellet within 8 hours is smaller than or equal to 85%. By using the sustained-release coating material, the drug is released stably by accurately controlling the sustained-release speed of potassium chloride inside the potassium chloride sustained-release pellet, an expected blood concentration is obtained, relatively long action time can be maintained, the phenomenon of sudden release does not exist, and adverse reactions such as stimulation for gastric mucosa can be avoided.

Description

Technical field [0001] The invention relates to the field of drug sustained-release and controlled-release preparations, in particular to a potassium chloride sustained-release pellet and a preparation method and application thereof. Background technique [0002] Potassium is the main cation inside the cell, and its concentration is 150-160mmol / L; while the main cation outside the cell is sodium ion, the potassium concentration is only 3.5-5mmol / L. The body mainly relies on Na on the cell membrane + -K + -ATPase to maintain K in the cell + , Na + Poor concentration. Normal intracellular and extracellular potassium ion concentration and concentration difference are closely related to some important functions of cells, including maintenance of carbohydrate metabolism, glycogen storage, protein metabolism, intracellular osmotic pressure and acid-base balance, and cardiac excitability and conductivity ; Maintain normal skeletal muscle tension and nerve impulse conduction, and increa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/50A61K47/38A61K47/32A61K33/14A61P3/12
CPCA61K9/5026A61K9/5047A61K9/5078A61K33/14
Inventor 冯利萍
Owner 杭州高成生物营养技术有限公司
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