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Oral cavity rapid release western medicine preparation and preparation thereof

A technology of quick-release preparations and manufacturing methods, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, oil/fat/wax non-effective ingredients, etc., and can solve problems such as excessive water absorption, low tablet strength, and difficulty in storage, etc. question

Inactive Publication Date: 2009-05-27
何煜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are many defects in these preparations, such as: granular feeling after disintegration, complicated preparation method, excessive water absorption is difficult to store, low tablet strength, etc.
Because the rapid release of the tablet is inversely proportional to the strength of the tablet, the amount of excipients is large and the amount of the main drug is limited
These dosage forms rely entirely on a small amount of water in the mouth to produce immediate release. When the saliva in the mouth is insufficient, the tablet will adhere to the oral mucosa and cause discomfort.
These problems are difficult to break through in the existing preparation mode

Method used

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  • Oral cavity rapid release western medicine preparation and preparation thereof
  • Oral cavity rapid release western medicine preparation and preparation thereof
  • Oral cavity rapid release western medicine preparation and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0116] Embodiment 1: the manufacture method of calcium preparation preparation

[0117] (1) Material preparation: 200Kg main material, auxiliary materials (sugar 300Kg, hydrogenated vegetable oil 300Kg, lecithin 10Kg)

[0118] (2) Refinement: use semi-dry method, roller grinding method (see Figure 6 ). Specifically: crush 200Kg of the main material to 200 mesh, add 300Kg of white sugar and 180Kg of hydrogenated vegetable oil (35-60°C) to mix, enter the two-roll mill (or three-roll mill) for pre-grinding to 60-150 microns, and then enter the five Grinding with a roller mill (or three-roll mill) to 20-35 microns. Then put the material into a refiner (blender) for refining (stirring) for 5 hours, during which 90Kg of hydrogenated vegetable oil is gradually added according to the viscosity of the material, and 30Kg is reserved to add together with lecithin 1 hour before the end. This process can also make white sugar into powdered sugar as a raw material. After the ingredients...

Embodiment 2

[0120] Embodiment 2: the manufacture method of calcium preparation preparation

[0121] (1) Material preparation: 200Kg main material, auxiliary materials (sugar 300Kg, hydrogenated vegetable oil 300Kg, lecithin 10Kg)

[0122] (2) Refinement: wet method, fine grinding method (see Figure 7 ). Specifically: grind 200Kg of main ingredients to 200 mesh, add (or add after mixing) successively with 300Kg powdered sugar and 270Kg hydrogenated vegetable oil (35-60°C) to grind to 25 microns. Reserve 30Kg of hydrogenated vegetable oil and add it together with lecithin 1 hour before the end.

[0123] (3) Molding: after fine grinding, discharge the material, pour it into a pre-set mold, then cool and solidify, take it out of the package, 10g / piece.

Embodiment 3

[0124] Embodiment 3: the manufacture method of calcium preparation preparation

[0125] (1) Material preparation: 200Kg main material, auxiliary materials (sugar 300Kg, hydrogenated vegetable oil 300Kg, lecithin 10Kg)

[0126] (2) Refinement: use wet method, ball milling method (see Figure 8). Specifically: grind 200Kg of the main ingredient to 200 mesh, add (or add after mixing) successively with 300Kg white sugar (or powdered sugar) and 300Kg hydrogenated vegetable oil (35-60°C) in a ball mill and grind to 25 microns. Lecithin is added successively during the grinding process.

[0127] (3) Molding: Discharge after ball milling, pour into a pre-set mold, then cool and solidify, take out the package, 10g / piece.

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Abstract

The invention relates to a western medicine oral immediate-release preparation and a manufacturing method thereof, the basic raw materials of the prepration comprise main materials and an auxiliary material, wherein, the main materials are western medicines comprising chemical medicines and biological products; the auxiliary material is an oily dispersant, and if necessary, a water-soluble dispersant, a corrective and a surfactant can be added; the weight percentage of the main materials is 0.1-80 percent, and the weight percentage of the auxiliary material is 20-99.9 percent. The specific preparation steps comprise: (1) preparation of materials; (2) preparation of slurry: the preparation comprises refining and liquefaction; the final fineness of the refining is 95 percent of the weight of the preparation is below 200 microns, the liquefaction process adopts a stirring method to lead solid particles to be dispersed in the oily dispersant; the weight percentage of the added amount of the oily dispersant causes the oil content in a finished product to be not less than 15 percent; (3) molding: a cooling molding method or a powder molding method is adopted to prepare a finished product preparation. The western medicine oral immediate-release preparation can improve the dispersion rate of western medicine ingredients in oral cavity under the premise of achieving a better taste, and the administration does not need to drink water, thereby being convenient.

Description

(1) Technical field: [0001] The invention provides a western medicine oral quick-release preparation and a manufacturing method thereof, belonging to the technical field of pharmaceutical preparations. (two) background technology: [0002] Oral immediate-release dosage form, as a new type of preparation, is more and more popular among consumers due to its unique advantages. The tablet does not need to be taken with water and dissolves quickly when it encounters saliva in the mouth, which provides convenience for some patients with poor swallowing function and inconvenient water intake, and has broad market prospects. This type of dosage form can disintegrate and dissolve quickly, has a quick onset of action, improves the absorption and bioavailability of the drug, and reduces the stimulating effect of the drug on the esophagus and gastrointestinal tract. At present, oral immediate-release preparations include two types of oral instant-dissolving preparations and oral rapid-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/44A61K47/24
Inventor 何煜
Owner 何煜
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