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A hollow capsule capable of controlling disintegration time limit and preparation method thereof

A technology of hollow capsules and disintegration time limit, which is applied in medical formula, medical preparations of non-active ingredients, drug delivery, etc., and can solve problems such as difficulty in determining the content of hollow capsules, uncontrollable disintegration time limit, and low pullulan , to avoid human absorption and metabolism problems, controllable disintegration time limit, and simplify the preparation process

Active Publication Date: 2016-08-17
JIANGSU LEFAN CAPSULE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nowadays, pullulan hollow capsules have been generally recognized by the market, but it is found that its storage stability is poor during use. After long-term storage, not only the color of the capsules will become darker, but also the phenomenon of brittleness will easily occur.
In addition, in order to control the properties of pullulan hollow capsules, the raw material components are usually more complex, so that the content of pullulan in the hollow capsules is lower, that is, the content of "healthy food materials" in the hollow capsules is lower, thus increasing the People are concerned about its safety. In addition, the disintegration time limit of the pullulan hollow capsules in the prior art is basically uncontrollable, and most of them need to be controlled by adding a fast disintegrant. It makes the preparation process of the hollow capsule more complicated, and on the other hand, the introduction of other ingredients will cause problems in the absorption and metabolism of the human body, which is not conducive to human health.
In addition, in the preparation process of pullulan hollow capsules, in order to reduce insoluble matter and air bubbles, there is usually a step of filtering the glue solution during the preparation process, but filtering the glue solution will not only lead to the content of each component of the hollow capsule Difficult to determine, will also cause a lot of waste

Method used

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  • A hollow capsule capable of controlling disintegration time limit and preparation method thereof
  • A hollow capsule capable of controlling disintegration time limit and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0021] A method for preparing a hollow capsule capable of controlling the disintegration time limit, the preparation steps are as follows: First, 3.8 parts of glycerin, 67 parts of potassium chloride, 160 parts of carrageenan and 3.8 parts of sodium lauryl sulfate and stirred separately until uniformly dispersed, then added 38,500 parts by mass of deionized water at 80°C, stirred until the system was completely dissolved, and added 7617 parts of pullulan while stirring after the solution was clarified, Finally, the glue is fully stirred, the stirring speed is 50r / min, the stirring time is 30min, and the glue is kept at 70°C for 4h, and then at 55°C for 7h; finally, the glue is molded by dipping the mold into glue, Dry at 28°C for 120 minutes to obtain the rubber base, and then remove the mold, cut and fit the rubber base to obtain the hollow rubber. The water content of the hollow capsule is 10wt%, and the disintegration time limit of the hollow capsule is 26 minutes, the succ...

Embodiment 2

[0023] A method for preparing a hollow capsule capable of controlling the disintegration time limit, the preparation steps are as follows: First, 3.9 parts of polyethylene glycol, 80 parts of potassium chloride, and 67 parts of carrageenan are sequentially added to 1500 parts by mass of deionized water at room temperature and 3.9 parts of sodium lauryl sulfate and stirred until uniformly dispersed, then added 38500 parts by mass of deionized water at 90°C, stirred until the system was completely dissolved, and added 7904 parts of Purus while stirring after the solution was clarified. Finally, fully stir the glue solution with a stirring speed of 55r / min and a stirring time of 40min, and keep the glue solution at 70°C for 5h, then heat and defoam at 50°C for 8h; Plastic molding, drying at 27°C for 150 minutes to obtain the rubber base, and then demoulding, cutting and fitting the rubber base to obtain the hollow rubber. The water content of the hollow capsule was tested to be 12...

Embodiment 3

[0025] A method for preparing a hollow capsule capable of controlling the disintegration time limit, the preparation steps are as follows: First, 3.9 parts of glycerin, 53 parts of potassium chloride, 133 parts of carrageenan and 4.0 parts of sodium lauryl sulfate and stirred separately until uniformly dispersed, then added 38500 parts by mass of deionized water at 85°C, stirred until the system was completely dissolved, and added 7896 parts of pullulan while stirring after the solution was clarified, Finally, fully stir the glue solution with a stirring speed of 60r / min and a stirring time of 25min, and keep the glue solution at 75°C for 4 hours, then heat and defoam at 55°C for 6 hours; finally, the glue solution is formed by dipping the glue mold into glue, Dry at 29°C for 160 minutes to obtain the rubber base, and then remove the mold, cut and fit the rubber base to obtain the hollow rubber. The water content of the hollow capsule is 11wt%, and the disintegration time limit...

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Abstract

The invention discloses an empty capsule capable of controlling disintegration time limit, and a preparation method thereof. The empty capsule comprises the following active ingredients: pullulan, humectants, a thickener, a coagulant aid, sodium dodecyl sulfate and deionized water. The formula is simple, glue liquor is not filtered in the preparation process of the empty capsule, and glue dipping is carried out after the pullulan is completely dissolved, so that the content of the pullulan in a finished product of the empty capsule is relatively high. The disintegration time limit of the empty capsule is controllable, and is regulated and controlled by controlling the mass ratio of the thickener to the pullulan, without the need of additionally adding a fast disintegrating agent, so that on one hand, the preparation technology of the empty capsule is simplified, and on the other hand, the absorption and metabolism problems of a human body caused due to introduction of other ingredients can also be avoided.

Description

technical field [0001] The invention relates to an auxiliary material for pharmaceutical preparations and a preparation method thereof, in particular to a hollow capsule capable of controlling the disintegration time limit and a preparation method thereof. Background technique [0002] Hollow capsules are currently widely used in pharmaceutical, food and cosmetic industries, and are the main excipients for processing pharmaceutical capsule preparations. Most of the currently used hollow capsules are made of gelatin, and the hollow capsules made of gelatin usually have some defects, such as the mad cow disease and foot-and-mouth disease that have occurred in various parts of the world in recent years. The prepared gelatin raw material produces obvious insecurity, and the gelatin hollow capsule also has defects such as easy hardening, brittleness and difficult disintegration in addition. Moreover, due to the limited source of gelatin, it will react with some drugs and has poo...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K47/36
Inventor 张轶弛
Owner JIANGSU LEFAN CAPSULE
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