Rabeprazole enteric-coated capsule and preparation method thereof
A technology of rabeprazole sausage and beprazole sausage, which is applied in the direction of capsule delivery, pharmaceutical formula, medical preparations containing active ingredients, etc., can solve the problems that affect the feasibility and reproducibility of the preparation process, the content is easy to drop, and the relative Poor capacity and other problems, to achieve the effect of stable properties, good quality, stable absorption
Inactive Publication Date: 2018-08-17
HANGZHOU SHARPLY PHARM R&D INSTIT +2
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- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
[0003] Rabeprazole sodium is a weakly basic compound with a sulfinyl group, which has poor stability under acidic conditions and is stable under alkaline conditions.
Therefore, the compatibility of rabeprazole sodium with certain excipients is poor, thereby affecting the feasibility and reproducibility of its preparation process
Because rabeprazole sodium is unstable to acid, it is made into common preparations, and the content of rabeprazole sodium is easy to decrease after being released in gastric acid
Method used
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Experimental program
Comparison scheme
Effect test
Embodiment 1
[0036] Embodiment 1: Preparation of rabeprazole enteric-coated capsules:
[0037] Materials used: 200g of rabeprazole emulsion, 200g of microcrystalline cellulose core, 416.7g of L30D-55 (aqueous dispersion of polyacrylic acid tri-resin), 20.8g of triethyl citrate.
[0038] The configuration of rabeprazole emulsion:
[0039] Rabeprazole Sodium 10g
[0040] Mineral oil 40g
[0041] Monoglycerides 40g
[0042] Glyceryl Behenate 8g
[0043] Span-60 1g
[0044] Polyethylene glycol oleate 1g
[0045] water 100g
[0046] making process:
[0047] 1. Emulsion Preparation
[0048] 1.1 Mineral oil, monoglycerides, and glyceryl behenate are heated to 50°C, and Span 60 and polyethylene glycol oleate are added to form an oil phase;
[0049] 1.2 Dissolve rabeprazole sodium in water and heat to 45°C to obtain an aqueous phase;
[0050] Under stirring, add the water phase to the oil phase, add triethanolamine, homogenize, and control the particle size of the emulsion droplet to 3-30 μ...
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Abstract
The invention relates to a rabeprazole enteric capsule and a preparation method thereof. The rabeprazole enteric capsule is prepared from (1) a blank pill core, (2) a rabeprazole emulsion, and (3) an enteric coating material. The rabeprazole emulsion comprises, 1-10% of rabeprazole sodium, 25-70% of water, 25-70% of an oil phase, 1-10% of a surfactant and 0.1-5% of a protective agent; the particle size of the blank pill core is controlled to be 18-80 mesh; and the weight gain of the enteric capsule is controlled to be 15%-30%. The obtained rabeprazole enteric capsule is prepared by preparing a water-in-oil type emulsion from rabeprazole sodium, then spraying the emulsion on the blank pill core and volatize water to enable rabeprazole sodium to be distributed on the pill core surface and enable the oil phase of the original emulsion to naturally form a separation dressing, and then performing enteric dressing and pellet filling, and the prepared pellet type enteric capsule is good in quality and stable in properties.
Description
technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to rabeprazole enteric-coated capsules and a preparation method thereof. Background technique [0002] Rabeprazole sodium (rabeprazole sodium) is a benzimidazole drug, developed by Japan's Eisai Company, first listed in Japan in 1998, clinically used for the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer, reflux Esophagitis, Zollinger-Ellison syndrome (gastrinoma). This product has fast onset of action and good acid suppression effect. It can continuously suppress acid and relieve symptoms for 24 hours. [0003] Rabeprazole sodium is a weakly basic compound with a sulfinyl group, which has poor stability under acidic conditions, but is stable under alkaline conditions. Therefore, the compatibility of rabeprazole sodium with certain excipients is poor, thereby affecting the feasibility and reproducibility of its preparation process. Because rabeprazole sod...
Claims
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IPC IPC(8): A61K9/48A61K31/4439A61P1/04A61P35/00
Inventor 范敏华孙军刘华周学来
Owner HANGZHOU SHARPLY PHARM R&D INSTIT