Enteric-coated pellet, preparation method thereof and preparation containing enteric-coated pellet
A technology of enteric-coated pellets and enteric-coated layers, applied in the field of ilaprazole enteric-coated pellets, its preparation method and preparations containing it, can solve the problem of stability and acid resistance, and reduce the risk of enteric-coated pellets And the stability of its preparations, acid resistance, can not be achieved and other problems, to achieve the effect of improving the dissolution rate, good acid suppression effect in the human body, and relieving pain
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Embodiment 1
[0114] Example 1: Preparation of enteric-coated pellets
[0115] In this Example 1, the enteric-coated pellets A-G according to the present invention will be prepared by taking ilaprazole and / or a pharmaceutically acceptable salt thereof as an example, as well as preparations for comparing the composition layers of the enteric-coated pellets. Comparative pellets 3-18 of the effect of different formulations on the properties of enteric-coated pellets and their formulations. Wherein, compared with the enteric-coated pellets A-G according to the present invention, the comparative pellets 3 and 4 have different ilaprazole particle sizes in the drug-loading layer; the comparative pellets 5-10, 14-15 have different isolation Layers; Comparative Pellets 11, 16, 17 had drug loading layers with altered formulations; and different protective layers for Pellets 12-13; Comparative Pellets 18 had altered ilaprazole and / or its pharmaceutically acceptable The ratio of salt to first excipien...
Embodiment 2
[0319] Example 2: Preparation of enteric-coated pellets
[0320] In this example 2, enteric-coated pellets A-G according to the present invention and comparative pellets 3-18 prepared in Example 1 were prepared into enteric-coated pellets A-G according to the present invention, and comparative pellets Pieces 3-18. In addition, also according to the preparation method of the enteric-coated micropill tablet of the prior art, with ilaprazole (particle size D90 is 46.8 μm, in order to facilitate the comparison between the data) as the medicinal active substance, prepared the comparative micropellet tablet 1 (according to CN1134666A) and comparative pellet 2 (according to CN102525990A).
[0321] 2.1 Preparation of enteric-coated pellets A-G according to the present invention and comparative pellets 3-18
[0322] Enteric-coated pellets shown in Table 1 and Tables 2-1 and 2-2 were prepared into enteric-coated pellets through the following steps of tableting and coating:
[0323] 1...
Embodiment 3
[0396] Example 3: Preparation of enteric-coated pellets
[0397] 600g of ilaprazole protective layer coated pellets A (W 1 +G 2 +C 1 +B 1 ) into a size 3 capsule shell via a capsule filler, containing +5 mg of ilaprazole in each capsule.
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