Sodium rabeprazole medicinal composite and method for preparing same

A technology of rabeprazole sodium and its composition, which is applied in the field of pharmaceutical preparations, can solve problems such as difficulty in preparing rabeprazole sodium solid preparations, large amount of alkaline stabilizer, and large total weight of dosage forms, etc., and achieve clinical compliance Good sex, low cost, suitable for swallowing effect

Inactive Publication Date: 2012-08-01
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, it is difficult to prepare rabeprazole sodium solid preparations that meet drug standards, such as tablets, capsules, granules, etc., using common pharmaceutical preparation molding techniques
[0006] Patent application 201110000086.4 discloses a composition of compound rabeprazole sodium pharmaceutical composition, wherein added alkaline substance sodium bicarbonate and (or) magnesium hydroxide as stabilizer, by weight, rabeprazole sodium: The ratio of sodium bicarbonate is 1: (55-168), or rabeprazole sodium: sodium bicarbonate: magnesium hydroxide is 1: (30-60): (35-70), and the amount of alkaline stabilizer is too large , is not conducive to the formation of prescriptions, and the total weight of the dosage form prepared with the same dosage is too large, generally (between 1170-3110mg), not suitable for swallowing, and can only be made into chewable tablets or dry suspensions or larger specifications Capsules, so clinical use compliance is poor

Method used

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  • Sodium rabeprazole medicinal composite and method for preparing same
  • Sodium rabeprazole medicinal composite and method for preparing same
  • Sodium rabeprazole medicinal composite and method for preparing same

Examples

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Embodiment 1

[0044] Table 1: Prescription

[0045]

[0046] Preparation Process:

[0047] Weigh the raw and auxiliary materials according to the prescription ratio in Table 1, first mix magnesium hydroxide, mannitol, and hydroxypropyl cellulose and pass through a 60-mesh sieve to mix evenly, then mix with the main ingredient of the prescription amount and pass through a 60-mesh sieve to Mix evenly, finally mix with magnesium stearate, powder direct compression preparation specification is 10mg, sheet weight is 116.15mg, tablet diameter is the rabeprazole sodium tablet of 7mm (can also directly fill No. 3 capsules and preparation specification is 10mg rabeprazole sodium capsules).

[0048] Those skilled in the art can also predict that the weight ratio of rabeprazole sodium: magnesium hydroxide: mannitol: hydroxypropyl cellulose: magnesium stearate is 10: 10: 80: 15: 1.15, 10: 30: 60 :15:1.15 or 10:50:40:15:1.15 formulations are also included in the present invention.

Embodiment 2

[0050] Table 2: Prescription

[0051]

[0052] Preparation Process:

[0053] Weigh the raw and auxiliary materials according to the prescription ratio in Table 2. First, mix anhydrous sodium carbonate, mannitol, and hydroxypropyl cellulose and pass through a 60-mesh sieve to mix evenly, then mix with the main ingredient of the prescription amount and pass through a 60-mesh sieve. To mix evenly, finally mix with magnesium stearate, powder direct compression preparation specification is 10mg, sheet weight is 116.15mg, tablet diameter is the rabeprazole sodium tablet of 7mm (can also directly fill No. 3 capsule preparation specification 10 mg rabeprazole sodium capsules).

[0054] Those skilled in the art can also predict that the weight ratio of rabeprazole sodium: anhydrous sodium carbonate: mannitol: hydroxypropyl cellulose: magnesium stearate is 10: 10: 80: 15: 1.15, 10: 30: Formulations of 60:15:1.15 or 10:50:40:15:1.15 are also encompassed by the invention.

Embodiment 3

[0056] Table 3: Prescription

[0057]

[0058]

[0059] Preparation Process:

[0060] Weigh the raw and auxiliary materials according to the prescription ratio in Table 3, first mix anhydrous sodium bicarbonate, mannitol, and hydroxypropyl cellulose and pass through a 60-mesh sieve to mix evenly, then mix with the main drug of the prescription amount and pass through a 60-mesh sieve Sieve until mixed evenly, and finally mix with magnesium stearate, and the powder is directly compressed into tablets to prepare rabeprazole sodium tablets whose specification is 10 mg, tablet weight is 116.15 mg, and tablet diameter is 7 mm (it can also be prepared by directly filling No. 3 capsules) The specification is 10mg rabeprazole sodium capsules).

[0061] Those skilled in the art can also predict that the weight ratio of rabeprazole sodium: anhydrous sodium bicarbonate: mannitol: hydroxypropyl cellulose: magnesium stearate is 10: 10: 80: 15: 1.15, 10: 30 :60:15:1.15 or 10:50:40:15...

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Abstract

The invention discloses a sodium rabeprazole medicinal composite, which contains the active substances of sodium rabeprazole and stabilizing agent, wherein the weight ratio of the stabilizing agent and the sodium rabeprazole is 0.05-10/1, and the sodium rabeprazole medicinal composite also contains other optional pharmaceutically acceptable additives. The composite uses less amount of the stabilizing agent, has good stability and a simple preparing technology.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition and a preparation method thereof, in particular to a rabeprazole sodium pharmaceutical composition and a preparation method thereof. Background technique [0002] Digestive system disease is one of the common frequently-occurring diseases, among which peptic ulcer is the main one, its mortality rate is very low, but it is often accompanied by serious complications, such as gastric and duodenal ulcers can be complicated by upper gastrointestinal tract Bleeding, perforation, etc., bring great misery to the patient and seriously threaten people's health. Proton pump inhibitors are effective drugs for the treatment of peptic ulcer disease. Rabeprazole sodium (Rabeprazole Sodium) is the fourth proton pump inhibitor (proton pump inhibitors, PPIs) after omeprazole, lansoprazole and pantoprazole, compared with the previous inhibitors, it has With ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/28A61K9/48A61K9/16A61K47/02A61K47/12A61K47/18A61K31/4439A61P1/04
Inventor 王玉丽单利高春生金欣杨美燕
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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