Rebeprazole sodium plain tablets, rebeprazole sodium enteric tablets and preparation method of rebeprazole sodium enteric tablets

A technology of rabeprazole sodium tablets and rabeprazole sodium, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of bioavailability of rabeprazole sodium Low rate, poor dissolution of tablet cores and other problems, to achieve the effect of high hardness, high dissolution and good stability

Active Publication Date: 2019-11-29
双鹤药业(海南)有限责任公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the above-mentioned technical problems, the invention provides a kind of rabeprazole sodium plain tablet, enteric-coated tablet and preparation method thereof, by improving the rabeprazole sodium component and its coating, the product dissolution rate and stability, at the same time, it solves the poor dissolution rate of the tablet core of rabeprazole sodium coated tablet or enteric-coated tablet, which leads to the low technical problem of the bioavailability of rabeprazole sodium; the present invention also provides the above-mentioned anti- A preparation method of rabeprazole sodium enteric-coated tablets, the preparation method is simple in process, reliable in quality, low in cost, and suitable for industrial application

Method used

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  • Rebeprazole sodium plain tablets, rebeprazole sodium enteric tablets and preparation method of rebeprazole sodium enteric tablets
  • Rebeprazole sodium plain tablets, rebeprazole sodium enteric tablets and preparation method of rebeprazole sodium enteric tablets
  • Rebeprazole sodium plain tablets, rebeprazole sodium enteric tablets and preparation method of rebeprazole sodium enteric tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] A kind of rabeprazole sodium element tablet, comprises the component of following weight portion:

[0057] Rabeprazole sodium 5-15 parts;

[0058] Mannitol 40-80 parts;

[0059] Betaine 1-2.5 parts;

[0060] 5-12 parts of light magnesium oxide;

[0061] Low-substituted hydroxypropyl cellulose 15-40 parts;

[0062] 0.5-1 part of pullulan polysaccharide;

[0063] 4-5.5 parts of calcium hydroxide;

[0064] 10-20 parts of talcum powder;

[0065] 0.5-3 parts of sodium stearyl fumarate.

[0066] Preferably, the granules of rabeprazole sodium, mannitol, betaine, light magnesium oxide, low-substituted hydroxypropyl cellulose, pullulan, calcium hydroxide, talc and hard sodium fumarate The diameter is 60-90 mesh; more preferably 80 mesh.

[0067] In some preferred embodiments, the mass ratio of mannitol to betaine is 30:1.

[0068] In some preferred embodiments, the rabeprazole sodium tablet also includes 4-5.5 parts by weight of meglumine, and more preferably, the mass ...

experiment example 1

[0083] Experimental example 1. Compatibility of raw materials and auxiliary materials.

[0084] Rabeprazole sodium is mixed with betaine and meglumine respectively in a mass ratio of 1:5, and rabeprazole sodium and pullulan are mixed in a mass ratio of 15:1, according to the 2010 edition of "Chinese Pharmacopoeia" Part Two Appendix XIXC-Guiding Principles for Stability Testing of APIs and Pharmaceutical Preparations Carry out testing of influencing factors to test the properties, related substances and content of the mixture. The test results are shown in Table 3-6.

[0085] Table 3 Rabeprazole sodium raw material experimental results

[0086]

[0087] The compatibility test result of table 4 rabeprazole sodium and betaine

[0088]

[0089] The compatibility test result of table 5 rabeprazole sodium and meglumine

[0090]

[0091] Table 6 Compatibility test results of rabeprazole sodium and pullulan

[0092]

[0093] It can be seen from Table 3-6 that after pla...

experiment example 2

[0094] Experimental Example 2 Dissolution of Rabeprazole Sodium Tablets

[0095] Get Rabeprazole Sodium Tablets, adopt dissolution assay (Chinese Pharmacopoeia 2010 edition two appendix XC first method) device, with phosphate buffer (pH6.8) (get 0.1mol / L hydrochloric acid solution and 0.2mol / L sodium phosphate solution, mix uniformly according to 3:1, if necessary, use 2mol / L hydrochloric acid solution or 2mol / L sodium hydroxide solution to adjust the pH value to 6.8) 1000mL is used as the solvent, and the speed is 75 revolutions per minute. Operate according to the law. At 45 minutes, take 10 mL of the solution, filter it, take the subsequent filtrate, add phosphate buffer (pH6.8) to dilute to make a solution containing about 10 μg per 1 mL, shake well, and use it as the test solution; Sodium prazole reference substance 10mg, accurately weighed, put in a 100mL measuring bottle, dissolve with water and dilute to the mark, shake up, accurately measure 5mL, put in a 50mL measur...

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Abstract

The invention discloses rebeprazole sodium plain tablets. The rebeprazole sodium plain tablets comprise the following components in parts by weight of 5-15 parts of rebeprazole sodium, 40-80 parts ofmannitol, 1-2.5 parts of betaine, 5-12 parts of light weight magnesium oxide, 15-40 parts of low substituted hydroxypropy cellulose, 0.5-1 part of pullulan polysaccharide, 4-5.5 parts of calcium hydroxide, 10-20 parts of talcum powder and 0.5-3 parts of sodium stearyl fumarate. The invention provides rebeprazole sodium enteric tablets containing the rebeprazole sodium plain tablets and a preparation method of the rebeprazole sodium enteric tablets. The preparation method comprises the following steps of S1, preparing the rebeprazole sodium plain tablets; S2, performing protective layer coating; S3, performing isolating layer coating; and S4, performing enteric layer coating. Rebeprazole sodium components and coating thereof are improved, dissolution and stability of products are promoted,and the technical problem that tablet core dissolution of the rebeprazole sodium coating tablets or enteric tablets is poor, so that the bioavailability of the rebeprazole sodium is low can be solved.

Description

technical field [0001] The invention relates to the technical field of rabeprazole sodium, in particular to a rabeprazole sodium plain tablet, an enteric-coated tablet and a preparation method thereof. Background technique [0002] Peptic ulcer is a common and frequently-occurring disease. Its death probability is very small, but it brings great pain to patients. Peptic ulcer is a well-defined mucosal disease that can penetrate the mucosal base layer and occurs in the area where the gastrointestinal tract is in contact with gastric juice. It can be found in the lesser curvature of the stomach, pyloric duct, duodenal bulb, and lower esophagus. Most of them are located in the stomach and duodenum, which is called gastric and duodenal ulcer disease. [0003] According to the theory of "no acid, no ulcer", acid suppressants have become the main drug for the treatment of peptic ulcer, especially proton pump inhibitors, such as omeprazole, rabeprazole sodium, yantoprazole, etc. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K9/32A61K31/4439A61K47/10A61K47/18A61P1/04
CPCA61K9/2013A61K9/2018A61K9/284A61K9/2866A61K9/2886A61K31/4439A61P1/04
Inventor 周培育张羽强蔡青蔓
Owner 双鹤药业(海南)有限责任公司
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