This product is made of gelatin for capsules and suitable enteric-coated materials, and is divided into two types: ordinary enteric-coated capsules
and colon-coated enteric-coated capsules.
【Properties】 This product is cylindrical, a hard and elastic hollow sac inset by the cap and the body. Capsule should be lighted
Clean, uniform color, smooth incision, no deformation, no odor. This product is divided into transparent (without pigment and titanium dioxide), semi-transparent
Bright (with pigment but no titanium dioxide), opaque (with titanium dioxide) three.
【Identification】 According to the tests of identification (1), (2) and (3) under the item of hollow capsule, the same reaction was shown.
[Check] Friability Take 20 capsules of this product, separate the cap and body, put them in a watch glass, and put them into a container containing magnesium nitrate [M
g(NO3)2·6H2O] saturated solution in a desiccator, set it at a constant temperature of 25℃±1℃ for 24 hours, take it out, and immediately use your thumb and index finger
Gently pinch the incision of the cap and body to form a joint, if broken, no more than 10 knots.
Colon-coated enteric-coated capsules are checked according to the above method, first checked in hydrochloric acid solution (9→1000) for 2 hours, and the amount of each capsule is
There should be no cracks or disintegration in the capsule shell; take out the hanging basket, wash it with a small amount of water, and then check it in phosphate buffer (pH 6.8) according to the above method for 3 hours, and each capsule should not have cracks or disintegration. After taking out the hanging basket, washing it with a small amount of water, and then checking it in phosphate buffer (pH 7.8) according to the above method, it should all melt or disintegrate within 1 hour (a small amount of shell fragments can be allowed to remain). If 1 capsule cannot be completely melted or disintegrated, another 6 capsules should be taken for retest, all of which should meet the requirements.
Tightness, loss on drying, chlorohydrin, residues on ignition and heavy metals were checked according to the methods under the hollow capsule, all were
meets the requirments.
【Uses】 It is used to hold solid drugs or other drugs that are easily destroyed in the stomach.
【Storage】 Sealed and stored in a cool and dry place.