High-density pellet core and preparation method thereof

A high-density, micro-pill technology, applied in the direction of metabolic diseases, bulk delivery, drug combination, etc., can solve the problems of not meeting energy conservation and environmental protection, low yield rate, cost increase, etc., to achieve drug adhesion and high yield rate , good roundness effect

Inactive Publication Date: 2016-10-12
张学怀
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is that the main material composition is mixed with a binder and made into a nearly round granule in a granulator, then dried and sieved to form a pellet core, wherein the main material composition consists of sucrose fine powder and Medicinal starch is mixed or selected from starch or microcrystalline cellulose alone, and the binder is mainly syrup. The micropills prepared in the invention have strong hygroscopicity due to containing sucrose and starch, and the yield is not high. Syrup needs to consume a lot of energy, which is not in line with the current concept of energy saving and environmental protection
[0004] At the same time, the starch and microcrystalline cellulose currently used are neutral substances, and sucrose is a weakly acidic substance. Some pharmaceutical ingredients need to use weakly alkaline pellet cores. If sucrose, microcrystalline cellulose and starch are used as raw materials, it is still Alkaline treatment of the pellet core is required, which increases the cost

Method used

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  • High-density pellet core and preparation method thereof
  • High-density pellet core and preparation method thereof
  • High-density pellet core and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A high-density medicinal pellet core, the components of the pellet core are listed in Table I.

[0035] Table I

[0036]

[0037]

[0038] Preparation method: Weigh the materials according to the amounts shown in Table I, heat the purified water to about 80°C, slowly add hydroxypropyl methylcellulose E50 to the hot purified water, add while stirring, and wait for the binding liquid to cool to room temperature Stand-by; the weighed calcium carbonate powder and microcrystalline cellulose are placed in the high-efficiency wet mixing granulator, and the calcium carbonate powder is calcium carbonate with a median particle diameter of 4.0 μm, and the mixing speed is set at 300rpm, shear The cutting rate is 1000rpm, and the mixing shear is turned on. After mixing and shearing for 3 minutes, slowly add the adhesive solution. After adding the adhesive solution, set the mixing rate to 300rpm and the shear rate to 1800rpm. After mixing and shearing for 2 minutes, the materia...

Embodiment 2

[0040] A high-density medicinal pellet core, the components of the pellet core are listed in Table II.

[0041] Table II

[0042]

[0043] Preparation method: Weigh the materials according to the amounts shown in Table II, slowly add polyethylene glycol 6000 to purified water, add while stirring, wait until the binding liquid becomes clear and transparent for use; add the weighed calcium carbonate Powder and microcrystalline cellulose are placed in a high-efficiency wet mixing granulator, the calcium carbonate powder is calcium carbonate with a median particle size of 30.0 μm, the mixing rate is set to 300 rpm, the shear rate is 1000 rpm, the mixing shear is turned on, and the mixing After shearing for 3 minutes, slowly add the adhesive solution. After adding the adhesive solution, set the mixing rate to 300rpm and the shear rate to 1800rpm. After mixing and shearing for 2 minutes, the material can be discharged to obtain a soft material; then turn on the extrusion spheroni...

Embodiment 3

[0045] A high-density medicinal pellet core, the components of the pellet core are listed in Table III.

[0046] Table III

[0047]

[0048] Preparation method: Weigh the materials respectively according to the amounts shown in Table III, slowly add hydroxypropyl cellulose into purified water, add while stirring, wait until the binding liquid becomes clear and transparent for later use; add the weighed calcium carbonate Powder and microcrystalline cellulose are placed in a high-efficiency wet mixing granulator, the calcium carbonate powder is calcium carbonate with a median particle size of 25.0 μm, the mixing rate is set to 300 rpm, the shear rate is 1000 rpm, the mixing shear is turned on, and the mixing After shearing for 3 minutes, slowly add the adhesive solution. After adding the adhesive solution, set the mixing rate to 300rpm and the shear rate to 1800rpm. After mixing and shearing for 2 minutes, the material can be discharged to obtain a soft material; then turn on...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a high-density medicinal pellet core and a preparation method thereof. The pellet core comprises the following components: 1500-2500 parts of a main ingredient composition, 55-85 parts of an adhesive; The main material composition is calcium carbonate powder. The calcium carbonate powder is calcium carbonate with a median particle size of 4.0 μm-30.0 μm. The particle diameter of the pellet core is 0.2-2.0mm. The preparation method is as follows: the main material composition is placed in a high-speed wet mixing granulator to mix evenly, and then the binder is added to make a soft material. The soft material is placed in an extrusion spheronizer to form a nearly spherical shape, and then placed in a Dried in a fluidized bed and sieved to form pellet cores. The invention has the characteristics of simple production process, wide source of raw materials and low price, high pellet yield, high density, low friability, uniform particle size, roundness and high surface finish.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a high-density pellet core and a preparation method thereof. Background technique [0002] Sustained and controlled release pellets, as a high-standard sustained and controlled release preparation, have developed rapidly in China in recent years. Compared with general preparations, it has three characteristics: First, it is convenient to take, and general preparations need to be administered several times a day It usually only needs to be administered 1-2 times a day; the second is that its effect is slower than that of general preparations, which avoids the sudden increase of effective blood drug concentration due to excessive fluctuations in blood drug concentration after frequent administration of general preparations The effect of the drug is improved and the side effects are reduced; the third is that the quality of the sustained-release pelle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K33/10A61P3/14
CPCA61K33/10A61K9/1652
Inventor 张学怀
Owner 张学怀
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