Alginate hard capsule disintegrable at different positions in gastrointestinal tract

Abstract

Disclosed is an alginate hard capsule disintegrable at different positions in gastrointestinal tract. Processing steps include preparing glue solution, glue solution dipping, solidifying, drying, drawing out, cutting, fastening, optical testing and sterilizing of glue solution and capsule filling. The glue solution is prepared by dissolving univalent alginate, plasticizer and pore former in water, wherein the pore former is a polymer film-forming material, glycerin and sorbitol serve as the plasticizer; the solidifying is that dipped gel solution is made into alginate gel capsule by means of ionic cross-linking or acidulating, wherein solidifying solution is multivalent metal ion water solution or acid solution; and finally active ingredients and disintegrating accelerator are filled in hard capsule shells to obtain finished products, wherein the disintegrating accelerator is a substance which can be in precipitation reaction or complexation with multivalent metal ions. The alginate hard capsule is widely applied to different disintegrating environments in the gastrointestinal tract and disintegrable in vivo at different speeds to release the active ingredients and has the advantages of high hydrothermal stability, simple preparation method and low cost.

Description

technical field [0001] The invention relates to a capsule for medicine and health food packaging, in particular to a hard capsule prepared from alginate gel as the main raw material. Background technique [0002] Hard capsules are made by filling a certain amount of medicinal material extracts with medicinal powder or auxiliary materials into uniform powder or granules, or by filling the medicinal material powder directly into hollow capsules. The production process is relatively simple, It has the advantages of convenient taking, fast onset of effect, and ability to effectively isolate the bad smell of medicines. [0003] At present, gelatin is mostly used as raw material for capsule shells at home and abroad, but because it is an animal-derived material, there is a risk of animal disease transmission and other food safety issues, and some chemical groups in gelatin are easily combined with aldehyde-containing substances. The chemical reaction of the drug ingredients will...

AI Technical Summary

Problems solved by technology

Due to the lack of enzymes to digest and degrade alginate in the human body, the disintegration of alginate hard capsules in the body mainly relies on ion exchange to form partially soluble alginate, but the ionic strength and pH in the human digestive tract vary from person to person, even if it is The environment in the digestive tract of the same person is different at different times and in different physical conditions, resulting in serious individual differences in the disintegration of alginate hard capsules in the digestive tract, especially for patients with poor gastrointestinal function. The ionic strength in the digestive tract is low, and the hard capsule shell made of alginate gel alone will cause delayed or no disintegration due to insufficient decrosslinking, which will affect the efficacy of the drug

Therefore, there is no mature hard capsule product made of alginate gel on the market at present.

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