Medicine can be a double-edged sword. If the drug is used reasonably, it can cure the disease; on the contrary, it can not cure the disease, but also affect the health of the body. According to the survey, drug errors accounted for 18.3% of medical errors in developed countries. Only by taking the medicine properly and reasonably can it be avoided and reduced.

Some drugs are prone to degeneration and decomposition of gastric acid, which has a strong stimulating effect on the gastric mucosa; some drugs must be absorbed in the intestine. It is precisely because of the special properties of some drugs and medical needs that the development of enteric coating materials has been promoted.

This standard specifies the specifications, technical indicators and requirements, test methods, inspection rules, criterion rule and requirements of product packaging, labeling, transportation and storage of empty enteric gelatin capsules.This standard is applicable to empty hard capsules made of gelatin and auxiliary materials and suitable enteric coating materials, divided into enteric-coated capsules and colonic enteric-coated capsules, gelatin and enteric materials should meet medicinal requirements.

For capsule coating, the content is depended on the area and thickness of the coating, and different coating solution is suitable for each different product.

In order to make the enteric coated capsules dissolve in the intestines, an enteric coating film generally contains the following ingredients: enteric film formers, plasticizers, anti-adhesion agents, colourants, other additives.

Enteric capsules are different from other general capsules. With added special medical polymer materials or other special treatments, capsule shell will dissolve not in the acidic gastric fluid, but in alkaline liquid in the intestinal tract. These capsules are mainly used for medications that need to disintegrate in the intestinal tract, and there are usually printed “CE” on the outer packaging for distinguishing.

Enteric capsules can release the drug in the small intestine and large intestine through drug delivery technology, so that the drug can exert local or systemic therapeutic effects in the human intestinal tract.

Enteric capsules are capsules that can only be dissolved and absorbed in the small intestine of the human body. The enteric capsule is a special medicinal polymer material added to the capsule shell or specially treated to make it dissolve in the gastric juice, and only dissolves in the intestinal juice. Therefore, the capsule will not be dissolved in the stomach, or in the water or even in the boiling water.