| Capsule is a kind of popular oral solid preparation, including hard capsule, soft capsule and enteric release capsule. Hard capsule is filled into some powder or granule which is made from medicinal materials and some excipients mixed. The hard capsule of the traditional Chinese medicine gets more and more extensive application in modern pharmaceutical industry in recent years, Because of the simple manufacture process, being taken conveniently , the quick effect and the advantage of masking bad smell availably. Most granules are easy to absorb moisture, whereafter become mass, even milden and rot due to different forms and ingredient' s complexity. It is a key reason that affects the drugs' quantity and curative.It is reported in some literatures that to resolve the capsule' s hygroscopic problem is paid attention by pharmaceutical industry all along, and there are some measures to solve it too. With the film coating ways, the trial uses modern pharmaceutical equipments and technology to study the model named Tian Ma Tou Feng Ling Capsule which absorbs moisture easily. With the index of moisture proof capacity, gain rate and coating time, Using the mathematical statistics methods, Through accelerated trial, The trial studies the familiar gastric release film coating product's moisture barrier capability mainly , studies the selection of film coating products and coating parameter and the suitable weight gain. The suitable film coating product and coating technical processes are screened out. The study result indicates that film coating can provide satisfied moisture proof for Tian Ma Tou Feng Ling Capsule. The technical parameter is reasonable and controllable. It is also offers a way to improve capsule' s moisture proof capability. |
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