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Preparation process of rabeprazole sodium enteric capsules

The technology of rabeprazole sodium and preparation process is applied in the field of pharmacy and can solve the problems of low production efficiency, long production cycle of rabeprazole sodium enteric-coated capsules, and high production cost, so as to improve production efficiency and improve bioavailability , the effect of reducing production costs

Active Publication Date: 2017-08-08
珠海润都制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0023] The present invention effectively solves the problems of long production cycle, low production efficiency and high production cost of rabeprazole sodium enteric-coated capsules, can not only improve the production efficiency of rabeprazole sodium enteric-coated capsules, reduce production costs, but also improve Bioavailability of rabeprazole sodium enteric-coated capsules

Method used

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  • Preparation process of rabeprazole sodium enteric capsules
  • Preparation process of rabeprazole sodium enteric capsules
  • Preparation process of rabeprazole sodium enteric capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0091] The processing of embodiment 1 calcium hydroxide micronization

[0092] Take by weighing the calcium hydrochloride coarse powder 5.06Kg of 80 mesh sieves, put jet mill (the model is QYF-100, manufactured by Miyou Group Co., Ltd.) to micronize, and pass through 200 mesh sieves to obtain micronized hydrochloride Calcium 3.58Kg, yield is 70.8%. Get the calcium hydroxide small sample after micronization, detect with Malvern laser particle size analyzer (model is Mastersizer2000, British Malvern instrument company manufactures), and D90 is 59.6um.

Embodiment 2

[0093] The preparation of embodiment 2 rabeprazole sodium enteric-coated capsules

[0094] A. Preparation of loaded pills

[0095] Weigh sodium hydroxide, rabeprazole sodium, highly substituted hydroxypropyl cellulose L, and Tween 80 successively according to the prescription design amount, dissolve them in 75% ethanol aqueous solution one by one, stir well, and be prepared into a viscose containing active pharmaceutical ingredients. Mixture, standby; Mannitol, low-substituted hydroxypropyl cellulose, calcium hydroxide are crossed 80 mesh sieves respectively, put wet granulator (G6 experimental multifunctional wet mixing granulator, Shenzhen Xinyite Machinery Co., Ltd. company), set the speed at 3 rpm, and mix for 5 minutes; add an appropriate amount of adhesive to the mixed material within 3 minutes, stir for 1 to 3 minutes, and shear at a speed of 5 to 10 rpm. Cut for 1 to 2 minutes to make a soft material; put the prepared soft material into an extruder (CGC-350 multifunct...

Embodiment 3

[0113] Example 3 Rabeprazole Sodium Enteric-Coated Capsules (Prescription 1, Prescription 2, Prescription 3, Prescription 4) prepared by the present invention are compared with the in vitro dissolution rate of the reference preparation (R)

[0114] Reference preparation (R): rabeprazole sodium enteric-coated capsules (trade name: ACIPHEX SPRINKLE).

[0115] Get each 6 rabeprazole enteric-coated capsules (prescription 1, prescription 2, prescription 3, prescription 4) and reference preparation (R) prepared in Example 2, detect its pH6.8 phosphate buffer saline by the following method in vitro dissolution rate.

[0116] Dissolution method: paddle method

[0117] (1) Acid medium: 0.1M hydrochloric acid solution

[0118] Acid medium volume: 750ml

[0119] Number of rotations: 100 rpm

[0120] Stop time: 120min

[0121] (2) Dissolution medium: pH6.8 buffer

[0122] Medium volume: 1000ml

[0123] Number of rotations: 50 rpm

[0124] Sampling time: 5, 10, 15, 20, 30, 45, 60 m...

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Abstract

The invention discloses a preparation process capable of improving bioavailability of rabeprazole sodium enteric capsules. The rabeprazole sodium enteric capsules prepared by the invention are prepared from rabeprazole sodium enteric mini-pills and hard capsule shells, wherein each rabeprazole sodium enteric mini-pill comprises a drug-loaded pill core, an isolation layer and an enteric layer; each drug-loaded pill is prepared from rabeprazole sodium, mannitol, low substituted hydroxypropy cellulose, high substituted hydroxypropyl cellulose L, calcium hydroxide, sodium hydroxide, and tween 80. Each isolation layer is prepared from ethyl cellulose, high substituted hydroxypropyl cellulose L and magnesium stearate; the enteric layer is prepared from acrylic resin, triethyl citrate and talcum powder. According to the preparation process, the production efficiency of the rabeprazole sodium enteric capsules can be improved, the produced rabeprazole sodium enteric capsules are uniform in quality, good in stability and high in dissolution in vitro; moreover, the bioavailability of rabeprazole sodium enteric capsules can be obviously improved, and the rabeprazole sodium enteric capsules have good market prospect.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a preparation process of rabeprazole sodium enteric-coated capsules. Background technique [0002] Proton pump inhibitors are benzimidazole compounds used for the treatment of peptic ulcer, esophageal reflux disease, gastrinoma syndrome and Helicobacter pylori. So far, the proton pump inhibitors that have been listed abroad include Omeprazole (Omeprazole), Esomeprazole (Esomeprazole), Pantoprazole (Pantoprazole), Levopantoprazole (S-pantoprazole), Rabe Rabeprazole, Dexrabeprazole, Lansoprazole, Dexlansoprazole, Ilaprazole, etc., domestic marketed proton pump inhibitors There are omeprazole, esomeprazole, pantoprazole, lansoprazole, rabeprazole, etc., and dex-rabeprazole, dex-lansoprazole, etc. are being applied for registration. Omeprazole was launched in the United States in 1988 and is the earliest benzimidazole proton pump inhibitor on the market. [0003] Rabeprazole sodium (CAS No.: ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/4439A61K47/38A61K47/32A61P1/04
CPCA61K9/5026A61K9/5047A61K9/5073A61K9/5089A61K31/4439
Inventor 谢斌陈新民杨冬朱俊杰杨刘增黄俊鹏王赛倾
Owner 珠海润都制药股份有限公司
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