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

Pending Publication Date: 2022-06-03
LIVZON PHARM GRP INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to obtain the desired effect, factors such as the number of coating layers, the thickness of each layer, the amount of intermediate layer adhesive and stabilizer must be adjusted, so the weight gain of each layer is strictly limited in this document, otherwise it cannot be achieved. The expected effect of the invention
[0010] There are following disadvantages in the prior art method that is used to prepare prazoles enteric-coated pellets and preparations thereof, cause the prazoles enteric-coated pellets of the prior art and preparations thereof can not have good stability and acid resistance ( Especially acid resistance is not easy to be satisfied): In the isolation layer of the prazole enteric-coated pellets prepared by the prior art, the isolation layer next to the core of the pill (that is, containing the pill) usually contains water that can prevent the pellets from sticking. Insoluble inert substances (such as talc, silicon dioxide, titanium dioxide, magnesium stearate, etc.) and / or water-soluble alkaline compounds, and the barrier layer next to the enteric layer usually contain alkaline compounds, both of which will reduce intestinal Stability and / or acid resistance of dissolved pellets and their formulations

Method used

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  • Enteric-coated pellet, preparation method thereof and preparation containing enteric-coated pellet
  • Enteric-coated pellet, preparation method thereof and preparation containing enteric-coated pellet
  • Enteric-coated pellet, preparation method thereof and preparation containing enteric-coated pellet

Examples

Experimental program
Comparison scheme
Effect test

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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Abstract

The invention relates to an enteric-coated pellet, a preparation method and a preparation thereof, and applications of the enteric-coated pellet and the preparation. The enteric-coated pellet sequentially comprises a pellet core, a first isolating layer, a second isolating layer and an enteric-coated layer from inside to outside, wherein the pellet core contains ilaprazole and/or pharmaceutically acceptable salt of ilaprazole and a first auxiliary material.

Description

technical field [0001] The present invention relates to an enteric-coated pellet, a preparation method thereof and a preparation containing the same, in particular to ilaprazole enteric-coated pellets, a preparation method thereof and a preparation containing the same. Background technique [0002] Proton pump inhibitors (PPIs) are capable of selectively inhibiting the secretion of H on the tubular membrane of human gastric mucosal cells. + / K + - Drugs for ATPase (also known as proton pump or acid pump). Due to the H + / K + -ATPase is the final pathway to inhibit gastric acid secretion, and its inhibition can significantly reduce gastric acid secretion. Therefore, proton pump inhibitors are usually used to treat diseases of the digestive tract caused or caused by gastric acid action (ie, acid-related diseases) , which include gastric and duodenal ulcers, gastroesophageal reflux disease, surgical anastomotic ulcers, and Zollinger-Ellison syndrome. According to the mecha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4439A61K47/02A61K47/38A61P1/04
CPCA61K9/5073A61K9/5089A61K9/5047A61K31/4439A61K47/02A61P1/04
Inventor 李普成崔艳南成彩华莫雅婷陈乐平侯雪梅张象娜张裕容胡斯文王涛涂增清李菁谭文绘
Owner LIVZON PHARM GRP INC
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