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Rabeprazole sodium tablet and rabeprazole sodium enteric-coated tablet

A technology of Rabeprazole Sodium Tablets and Beprazole Sodium Tablets, which is applied in the directions of medical preparations of non-active ingredients, pill delivery, digestive system, etc., and can solve the problem of low bioavailability of Rabeprazole Sodium and tablet Solve problems such as poor core dissolution rate, achieve good dissolution rate and high bioavailability

Active Publication Date: 2015-09-02
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Because proton pump inhibitors are unstable in acidic environments, rabeprazole sodium is usually prepared into coated tablets or enteric-coated tablets for oral use, but the rabeprazole sodium coated tablets or enteric-coated tablets provided by the prior art Poor dissolution of tablet core, resulting in low bioavailability of rabeprazole sodium

Method used

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  • Rabeprazole sodium tablet and rabeprazole sodium enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Embodiment 1 Compatibility experiment of auxiliary materials

[0063] Mix rabeprazole sodium with lactose, microcrystalline cellulose, magnesium aluminum silicate, and magnesium oxide in a mass ratio of 1:5; rabeprazole sodium and microcrystalline cellulose are mixed in a mass ratio of 20:1. Mix, after mixing evenly; According to the method of influencing factors respectively, under the conditions of high temperature 40 ℃, high humidity 90%, light (4500Lx), place the sample after 10 days, investigate its properties and related substances, the results are shown in Table 1, table 1 is the experimental result of excipient compatibility provided by the embodiment of the present invention.

[0064] The excipient compatibility experiment result that table 1 the embodiment of the present invention provides

[0065]

[0066]

[0067] It can be seen from Table 1 that after rabeprazole sodium is mixed with various auxiliary materials, there is no obvious change in the dete...

Embodiment 2 and comparative example 1～3

[0068] Embodiment 2 and comparative example 1~3 prescription screening

[0069] Rabeprazole sodium tablets were prepared according to the prescription in Table 2. Table 2 shows the prescription and performance test results of the rabeprazole sodium tablets provided in Example 2 and Comparative Examples 1-3.

[0070] After mixing the various substances in the prescription in Table 2 evenly, add ethanol with a mass concentration of 75% to prepare a soft material, dry it at 50°C and compress it into tablets to obtain rabeprazole sodium plain tablets.

[0071] Test the dissolution rate of rabeprazole sodium tablet according to the following method:

[0072] 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...

Embodiment 3

[0076] Example 3 screening of spacer fluid dosage

[0077] The spacer solution includes a medicinal gastric-soluble film coating premix with a mass ratio of 27:309 and an ethanol solution with a mass concentration of 85%.

[0078] Select the amount of spacer liquid relative to the Rabeprazole Sodium Tablets prepared in Example 2 to increase the weight by 3-4%, 6-7%, 7-8%, and detect whether it is effective for the Rabeprazole Sodium Tablets prepared after coating treatment. The quality of the sodium prazole product is affected, and the weight gain of the rabeprazole sodium plain tablet prepared by the intestinal solution relative to Example 2 is fixed at 10%. The test results are shown in Table 3, and Table 3 is the screening of the amount of spacer solution provided by the embodiment of the present invention result.

[0079] Table 3 Screening results of spacer fluid dosage provided by the embodiments of the present invention

[0080]

[0081]

[0082] It can be seen f...

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Abstract

The invention provides a rabeprazole sodium tablet which comprises the following components in part by weight: 20-40 parts of rabeprazole sodium, 260-300 parts of lactose, 50-80 parts of magnesium silicate, 35-45 parts of magnesium oxide and 1-5 parts of microcrystalline cellulose. According to the invention, the components of the rabeprazole sodium tablet and the dosage of each component are controlled, and the rabeprazole sodium tablet has high dissolution rate and bioavailability through the integrated action of all components and is reasonable in component design. Experimental results show that the dissolution rate of the rabeprazole sodium tablet is 97.5%. The invention further provides a rabeprazole sodium enteric-coated tablet which is prepared from the rabeprazole sodium tablet above; the rabeprazole sodium tablet is reasonable in component design, so that the prepared rabeprazole sodium enteric-coated tablet has good stability.

Description

technical field [0001] The invention relates to the technical field of rabeprazole sodium, in particular to a rabeprazole sodium plain tablet and rabeprazole sodium enteric-coated tablet. 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. Inhibitors hav...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K31/4439A61K47/38A61P1/14
Inventor 李明杰杨丽娟冯长运
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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