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Hard capsules with enteric film coating

A technology of hard capsules and hard capsule shells, applied in the directions of capsule delivery, carbon active ingredients, drug delivery, etc., can solve the problems of abnormal epithelial cell function, abnormal white blood cell function, increase liver toxicity, etc., to reduce absorption and help wound healing. , the effect of reducing damage

Active Publication Date: 2013-12-04
CHENHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Secondly, taking p-cresol as an example, although 10% of free p-cresol can be removed by hemodialysis, 90% of p-cresol will bind to proteins in the blood circulation, resulting in abnormal epithelial cell function, abnormal white blood cell function, Increase liver toxicity, cause inflammatory reactions, etc.

Method used

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  • Hard capsules with enteric film coating
  • Hard capsules with enteric film coating
  • Hard capsules with enteric film coating

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] First, according to Table 1, take 50.0mg of EUDRAGIT S100 ( GmbH & Co. KG, Darmstadt, Germany), 17.5 mg of triethyl citrate, 17.5 mg of propylene glycol, 2.5 mg of glyceryl monostearate, 1.0 mg of Tween80, mix well and dissolve in pure water to form Enteric film coating solution. Then, using a known sealing method, the thin strip made of hydroxypropyl methylcellulose is directly pasted on the outside of the hard capsule shell and overlaps with the joining area of ​​the capsule cap and the capsule body.

[0065] Then, soak the gelatin hard capsules filled with activated carbon (with spherical shape and irregular surface) in the enteric film coating solution and quickly take out and dry, or evenly spray the enteric film coating solution on the surface of the hard capsule and Dry to form hard capsules with an enteric film coating.

[0066] The obtained enteric-coated hard capsules were tested according to the evaluation methods described later, and the results are shown...

Embodiment 2 to 8

[0068] With the preparation method of the hard capsule of the enteric film coating of embodiment 1, difference is that embodiment 2 to 8 changes the kind and the consumption of raw material in the enteric film coating composition, and its formula and test result are as shown in table 1, No further details here.

Embodiment 9 to 15

[0070] With the preparation method of the hard capsule of the enteric film coating of embodiment 1, difference is that embodiment 9 to 15 changes the kind of raw material in the enteric film coating composition, usage amount and the solvent of dissolving, and its formula and test result are as table 1, and will not be repeated here.

[0071]

[0072] assessment method

[0073] 1. Dissolution test:

[0074] First, to simulate the environment of the gastrointestinal tract, the enteric film-coated hard capsules of Examples 1 to 15 were first added to 900 mL of a buffer solution with pH 1.2 to simulate the environment in the stomach, and the mixture was heated at 37.5 °C at a speed of 100 rpm. Continue stirring for 120 minutes, wherein the buffer solution is prepared from potassium chloride, sodium chloride, dipotassium hydrogen phosphate and sodium hydroxide or any combination of the above. It should be added that the buffer solution is well known to those skilled in the art...

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Abstract

The present invention provides a hard capsule with enteric film coating, which is a particular advantage of the sealing structure and the enteric film coating composition coated hard gelatin capsules, hard gelatin capsules so that the enteric film coating in the stomach and small intestine with complete shape, but may disintegrate in the large intestine and the release point of the hard capsule shell activated carbon, thereby selectively adsorbing the pro-protein small molecule compounds such as indole, indoxyl sulfate, p-cresol, hippuric acid and the like. Further, the resultant film-coated hard gelatin capsules may be enteric prevention or treatment of a liver disease or kidney disease a pharmaceutical composition.

Description

technical field [0001] The invention relates to a hard capsule with an enteric film coat, and in particular to a hard capsule with an enteric film coat for fixed-point release in the large intestine. Background technique [0002] There are dozens of substances that will accumulate in the body when renal function declines, which can be roughly divided into the following three categories: (1) small, water-soluble non-protein-bound compounds (small, water-soluble non-protein-bound compounds), that is, molecular weight Compounds less than 300 Dalton (dalton; Da), such as urea, Creatinine, etc. (2) Middle molecules, that is, compounds with a molecular weight ranging from 300 to 12,000 Daltons, such as peptides and β2 microglobulin. (3) Small, protein-bound compounds, that is, compounds with a molecular weight less than 300 Daltons, such as p-cresol, indoxyl sulfate, hippuric acid, etc. Among them, if the small molecular protein-friendly compounds accumulated in the body are not...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J3/07A61K9/30A61K9/32A61K33/44A61P13/12A61P1/16
Inventor 王伟明谢俊宇王郁杰陈韦良
Owner CHENHO PHARMA
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