As a coating material for oral medicine, medicinal capsule shells have relatively high requirements for use, whether it is the material requirements for itself or the acceptability for the human body. Specifically, there are several requirements for it.

Exterior

It should be clean and free of sticking, deformation, leakage, or rupture of the capsule shell, and should have no peculiar smell

moisture

The moisture content of the hard capsule contents shall not exceed 9.0%, and the moisture content shall not be checked if the contents of the hard capsules are liquid or semi-solid

Disintegration time limit

Hard capsules should be completely disintegrated within 30 minutes;

Soft capsules should disintegrate completely within 1 hour (soft capsules based on gelatin are tested in artificial gastric juice);

Enteric-coated capsules should be inspected in hydrochloric acid solution (9→1000) for 2 hours. The capsule shell of each capsule should not have any cracks or disintegration. Instead, it should be inspected in artificial intestinal juice, and it should be completely disintegrated within 1 hour;

Colonic enteric-coated capsules are first inspected in hydrochloric acid solution (9→1000) for 2 hours, the capsule shell of each capsule must not have cracks or disintegration, and then inspected in phosphate buffer solution (pH6.8) for 3 hours, each capsule The capsule shell should not have cracks or disintegration, and should be checked in phosphate buffer solution (pH7.8), and it should be completely disintegrated within 1 hour;

Capsules that require inspection of dissolution or release are generally no longer subject to disintegration time limit inspection

Release

Sustained-release, controlled-release, and enteric-coated capsules should comply with relevant regulations and be inspected

Loading difference

Average weight or labeled quantity: 0.30g, loading quantity difference limit: ±10.0%

Average weight or marked amount: 0.30g or more, the limit of difference in loading amount: ±7.5% (traditional Chinese medicine is ±10.0%)

There shall not be more than 2 capsules exceeding the limit of difference in filling quantity, and no one capsule shall exceed the limit;

For capsules that are required to check the content uniformity, the inspection of the difference in filling volume is generally no longer required

other

Microbiological limits, qualitative identification and content determination of drugs, etc. should comply with the relevant regulations under each category;

Capsules should be stored in a sealed environment, the storage environment should not be higher than 30°C, and the humidity should be suitable to prevent moisture, mold, and deterioration