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A kind of coating liquid composition of erythromycin enteric-coated pellets

An enteric-coated pellet and enteric-coated technology are applied in the preparation of the erythromycin enteric-coated pellets, the preparation of the boiling-coating granulator, and the field of erythromycin enteric-coated pellets, which can solve the problem of less equipment and granules. Small diameter, small particle size and other problems, to achieve the effect of reducing production cost, high production efficiency and cost saving

Active Publication Date: 2011-12-14
浙江华润三九众益制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] Chinese Patent No. 00114205.4 discloses granules with a coating layer, but this document does not study the preparation in depth, and needs to use multi-layer coatings in the implementation, and the particle diameters of internal medicine particles such as erythromycin wrapped therein are relatively small (40~ 100 mesh, less than 0.45mm), making the specific surface area larger
[0004] Chinese patent application No. 200410006228.8 discloses an enteric-coated tablet of erythromycin pellets, which has a complex formula, uses isolation gown materials, lubricants and glidants, etc., and requires multi-layer packaging
[0005] Although Chinese Patent Application No. 20051005411.0 can select the preparation form of erythromycin derivative enteric-coated tablets, this document does not study the preparation form in depth, nor does it disclose erythromycin
[0006] Chinese Patent No. 20051013661.8 discloses a kind of dirithromycin enteric-coated pellets, which not only does not suggest the use of erythromycin, but more seriously, it increases the size of the dirithromycin through a complicated ball core and adhesive formula system. The particle size of the internal drug particles, and the use of an isolation layer and an enteric layer system, make the formulation and preparation more complicated
[0008] Chinese patent application No. 200810114585.4 discloses a dirithromycin enteric-coated granule, which not only does not suggest the use of erythromycin, but also has a small particle size (35-45mm, less than 0.5mm) inside the drug granule, making the specific surface area larger
[0009] Chinese patent application No. 200910014682.0 discloses a dirithromycin enteric-coated preparation, which not only does not suggest the use of erythromycin, but more seriously, it uses a barrier layer and an enteric-coated layer system, so that the formulation and preparation quite complicated
[0010] The Chinese patent No. 200810069467.6 closest to the present invention discloses an erythromycin enteric-coated capsule, which contains enteric-coated pellets. The formula and preparation process are relatively simple, but castor oil is used in the formula; and the enteric-coated capsule is prepared Pellets need to use the BZJ-1000EⅡ centrifugal coating granulator, and the comprehensive cost of the centrifugal coating granulator (including price and operation and maintenance costs) is much higher than that of the boiling coating granulator. Less equipment, in addition, the particle size of the pellets is small (0.6-0.8mm), which makes the specific surface area larger
[0011] In addition, Chinese patent application No. 201010216768.4 discloses an erythromycin enteric-coated tablet, the formula is relatively complicated, especially castor oil is also used

Method used

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  • A kind of coating liquid composition of erythromycin enteric-coated pellets
  • A kind of coating liquid composition of erythromycin enteric-coated pellets

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Example 1 Preparation Example 1 of Enteric-coated Pellets

[0033] (1) Put 1 part of polyacrylic acid resin II in 15 parts of 95% (v / v) ethanol, after the polyacrylic resin is fully dissolved, add 0.15 parts of diethyl phthalate and 0.15 parts of Tween-800, and stir After uniformity, the enteric coating solution is obtained and set aside.

[0034] (2) Mix 1 part of erythromycin and 0.2 part of dextrin, add 0.15 part of 4% (w / w) hydroxypropyl methylcellulose (HPMC) solution, and mix in CH-150 tank mixer (available from (Jiangyin Zhongrui Drying Equipment Co., Ltd.) was fully mixed, and then extruded with a TC-42 extruder (available from Guangdong Henglian Food Machinery Co., Ltd.) and then extruded with a QZL-550 spheronizer (available from Changzhou Jiafa). Granulating Drying Equipment Co., Ltd.) into granules, and finally dried with a CT-C-III hot air circulation oven (available from Jiangyin Zhongrui Drying Equipment Co., Ltd.) to make pellets with an average particl...

Embodiment 2

[0037] Example 2 Preparation Example 2 of Enteric-coated Pellets

[0038] (1) Put 1 part of polyacrylic resin II in 18 parts of 95% (v / v) ethanol, after the polyacrylic resin is fully dissolved, add 0.2 parts of diethyl phthalate and 0.2 parts of Tween-800, and stir After uniformity, the enteric coating solution is obtained and set aside.

[0039] (2) Mix 1 part of erythromycin and 0.2 part of dextrin, add 0.15 part of 4% (w / w) hydroxypropyl methylcellulose solution, mix well in a CH-150 tank mixer, and then use Extruded by TC-42 extruder and spheronized into particles by QZL-550 spheronizer, and finally dried by CT-C-III hot air circulation oven to make pellets with an average particle size of 1.0 mm for future use.

[0040] (3) Place the pellets prepared in step (2) in a BF120B boiling coating machine, adjust to stabilize the inlet air temperature at 60°C and the outlet air temperature at 40°C, and put the enteric-coated pellets prepared in step (2) into The coating soluti...

Embodiment 3

[0042] Example 3 Preparation Example 3 of Enteric-coated Pellets

[0043] (1) Put 1 part of polyacrylic resin II in 22 parts of 95% (v / v) ethanol, after the polyacrylic resin is fully dissolved, add 0.25 parts of diethyl phthalate and 0.25 parts of Tween-800, and stir After uniformity, the enteric coating solution is obtained and set aside.

[0044] (2) Mix 1 part of erythromycin and 0.2 part of dextrin, add 0.15 part of 4% (w / w) hydroxypropyl methylcellulose solution, mix well in a CH-150 tank mixer, and then use Extruded by TC-42 extruder and spheronized into granules by QZL-550 spheronizer, finally dried by CT-C-III hot air circulation oven to make pellets with an average particle size of 1.2 mm for future use.

[0045] (3) Place the pellets prepared in step (2) in a BF120B boiling coating machine, adjust to stabilize the inlet air temperature at 60°C and the outlet air temperature at 40°C, and put the enteric-coated pellets prepared in step (2) into The coating solution ...

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Abstract

The invention provides an erythromycin enteric-coated pellet which is suitable to be prepared by a boiling coating granulator, wherein the enteric-coated coating liquid comprises polyacrylic resin II, diethyl phthalate, tween-80, and an ethanol solution. In addition, the invention also provides a process and an intermediate material for preparing the erythromycin enteric-coated pellet, such as enteric-coated coating liquid and the like.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention relates to erythromycin enteric-coated pellets, which are suitable for preparation by using a boiling coating granulator. In addition, the present invention also relates to a process for preparing the erythromycin enteric-coated pellets and intermediate materials, such as coating solution and the like. technical background [0002] Erythromycin belongs to the class of antibiotics and has a strong inhibitory effect on most Gram-positive bacteria and some Gram-negative bacteria, especially for cases of drug resistance and allergy to penicillin. Erythromycin is unstable in case of acid and is more irritating to the gastric mucosa, so its oral preparations are usually in the form of enteric-coated preparations. [0003] Chinese Patent No. 00114205.4 discloses granules with a coating layer, but this document does not study the preparation in depth, and needs to u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K9/48A61K31/7048A61K47/38A61K47/36A61K47/34A61P31/04
Inventor 金鑫朱菊红王旦钱艳芬周益成
Owner 浙江华润三九众益制药有限公司
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