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A kind of potassium chloride sustained-release pellets and its preparation method and application

A technology of slow-release pellets and potassium chloride pellets, which is applied in the direction of active ingredients of alkali/alkaline earth metal chlorides, microcapsules, and pharmaceutical formulations, can solve problems such as potential safety hazards, prolonging process time, and air pollution, and achieve anti-corrosion Strong water permeability, good reproducibility of release, and the effect of saving manufacturing costs

Active Publication Date: 2021-04-06
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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  • A kind of potassium chloride sustained-release pellets and its preparation method and application
  • A kind of potassium chloride sustained-release pellets and its preparation method and application
  • A kind of potassium chloride sustained-release pellets and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Step 1: Making the pellet core:

[0063] Percentage by weight: starch: 20%, sucrose: 70%, dextrin: 9%, 30% syrup solution as binder.

[0064] a. Sucrose is pulverized and processed into a powder of less than 80 meshes, and starch is added, and dextrin is mixed evenly by 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 engine of the coating granulator at a speed of 80r / min. Blower wind pressure: 0.03Kpa. The 30% syrup solution passes through the 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. Place the sugar pellets in a fluidized bed for boiling drying, control the air inlet temperature at 90-110 degrees, dry for 30-40 minutes, and keep the water content ≤ 5%, and pass through the sieving to make the sugar pellets with a target particle size of 0.2-0.4mm.

[0066] Step 2: Production of the...

Embodiment 2

[0085] Step 1: Making the pellet core:

[0086] Percentage by weight: starch: 25%, sucrose: 65%, dextrin: 10%, purified aqueous solution as binder.

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

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

[0089] c. Put the mixed powder in the coating granulator and start the main engine of the coating granulator at a speed of 70r / min. Blower wind pressure: 0.04Kpa. The purified aqueous solution is atomized and sprayed onto the rotating mixed powder through a peristaltic pump at a speed of 45r / min to form sugar pellets, which are placed in a fluidized bed to boil and dry. Minutes, dried in a fluidized bed, moisture ≤ 5%, and sieved to make it into a sugar pill with a target particle size of 0.2-0.4mm.

[0090] Step 2: Production of the main drug layer:

[0091] a. Percentage by weight: get sugar pill 4%, crushed potassium chloride: 93%, micr...

Embodiment 3

[0109] Step 1: Making the pellet core:

[0110] Percentage by weight: starch: 20%, sugar: 70%, dextrin; 9%, 50% syrup solution as binder.

[0111] a. The sugar is pulverized and processed into a powder of less than 80 meshes, and the starch and dextrin are mixed evenly by a mixer to make a mixed powder of sugar, starch and dextrin.

[0112] b. Put the mixed powder in the coating granulator and start the main engine of the coating granulator to rotate at a speed of r / min50. Blower wind pressure: 0.02Kpa. The 30% syrup solution passes through the peristaltic pump with a rotational speed of r / min: 75. Atomized and sprayed onto the rotating mixed powder through a spray gun to form sugar pellets. Put the sugar pellets in the fluidized bed for boiling drying, control the air inlet temperature at 90-110 degrees, dry for 35-45 minutes, set the temperature in the fluidized bed at 100°C, moisture ≤ 5%, and pass through the sieve to make it into the target pellets The diameter is 0.2...

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Abstract

The invention relates to a potassium chloride sustained-release pellet and a preparation method and application thereof. The invention provides a potassium chloride sustained-release pellet, which comprises a pellet core, a potassium chloride main drug layer, an isolation layer, a sustained-release coating layer and a color coating layer. The release amount of the potassium chloride sustained-release pellets prepared by the invention is ≤25% in 1 hour, ≤70% in 4 hours, and ≤85% in 8 hours. The present invention uses the slow-release coating material, and by accurately controlling the slow-release rate of potassium chloride in the potassium chloride slow-release pellets, the drug release is stable, and the expected blood drug concentration can be obtained, and can maintain a long action time without delay. There is a burst release phenomenon, which can avoid adverse reactions such as irritation to the gastric mucosa.

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 in the cell, and its concentration is 150-160 mmol / L; while the main cation outside the cell is sodium ion, and the concentration of potassium is only 3.5-5 mmol / L. The body mainly relies on Na on the cell membrane + -K + -ATPase to maintain intracellular K + 、Na + Concentration difference. Normal intracellular and intracellular potassium ion concentrations and concentration differences are closely related to some important functions of cells, including maintaining carbohydrate metabolism, glycogen storage, protein metabolism, intracellular osmotic pressure and acid-base balance, myocardial excitability and conductivity ; Maintain normal tension of skeletal muscle and nerve impulse ...

Claims

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Application Information

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Patent Type & Authority Patents(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