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Repaglinide common tablets and preparation method thereof

A technology of ordinary tablets and fillers, which is used in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of poor stability, low dissolution rate of repaglinide tablets, and high impurity content. problem, to achieve the effect of stable quality, weak hydrophobicity and simple process

Active Publication Date: 2014-07-16
ZHEJIANG YATAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The present invention aims at the disadvantages of low dissolution, high impurity content and poor stability of the repaglinide tablets produced in the prior art, and provides a repaglinide whose dissolution effect, disintegration effect and stability are all superior to the prior art Ordinary film

Method used

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  • Repaglinide common tablets and preparation method thereof
  • Repaglinide common tablets and preparation method thereof
  • Repaglinide common tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A common repaglinide tablet, comprising the following raw materials in parts by weight:

[0028]

[0029]

[0030] Among them, the solubilizer is meglumine, the binder is hypromellose, the disintegrant is carboxymethylcellulose calcium, the lubricant is sodium stearyl fumarate, the filler is 55 parts of mannitol, corn starch 25 parts, 75 parts of calcium hydrogen phosphate, 18 parts of microcrystalline cellulose.

[0031] A preparation method of repaglinide common sheet, comprising the steps of:

[0032] Step 1: pulverize repaglinide, sieve, and weigh the prescription amount for later use;

[0033] Step 2: Weighing the solubilizer, binder, disintegrating agent and filler of the prescribed amount, mixing evenly, and preparing auxiliary materials for use;

[0034] Step 3: mix the excipients prepared in step 2 with the repaglinide prepared in step 1 according to the principle of equal increase, add the prescribed amount of lubricant, and mix evenly;

[0035] Step ...

Embodiment 2

[0037] A common repaglinide tablet, comprising the following raw materials in parts by weight:

[0038]

[0039]

[0040] Wherein, the solubilizer is meglumine, the binder is povidone K30, the disintegrant is carboxymethylcellulose calcium, and the lubricant is sodium stearyl fumarate.

[0041] A preparation method of repaglinide common sheet, comprising the steps of:

[0042] Step 1: pulverize repaglinide, sieve, and weigh the prescription amount for later use;

[0043] Step 2: Weighing the solubilizer, binder, disintegrating agent and filler of the prescribed amount, mixing evenly, and preparing auxiliary materials for use;

[0044] Step 3: mix the excipients prepared in step 2 with the repaglinide prepared in step 1 according to the principle of equal increase, add the prescribed amount of lubricant, and mix evenly;

[0045] Step 4: Test the intermediate content, calculate the tablet weight according to the specifications and intermediate content data, and use the s...

Embodiment 3

[0047] A common repaglinide tablet, comprising the following raw materials in parts by weight:

[0048]

[0049]

[0050] Wherein, the solubilizer is meglumine, the binder is povidone K30, the disintegrant is carboxymethylcellulose calcium, and the lubricant is sodium stearyl fumarate.

[0051] A preparation method of repaglinide common sheet, comprising the steps of:

[0052] Step 1: pulverize repaglinide, sieve, and weigh the prescription amount for later use;

[0053] Step 2: Weighing the solubilizer, binder, disintegrating agent and filler of the prescribed amount, mixing evenly, and preparing auxiliary materials for use;

[0054] Step 3: mix the excipients prepared in step 2 with the repaglinide prepared in step 1 according to the principle of equal increase, add the prescribed amount of lubricant, and mix evenly;

[0055] Step 4: Test the intermediate content, calculate the tablet weight according to the specifications and intermediate content data, and use the sem...

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Abstract

The invention relates to the field of pharmaceutical preparations, and discloses repaglinide common tablets and a preparation method thereof. The repaglinide common tablets comprise the following raw materials by weight: 2 parts of repaglinide, 2.4-2.8 parts of a solubilizer, 4.5-5.5 parts of a binder, 7-9 parts of a disintegrating agent, 1-3 parts of a lubricant, and 155-173 parts of a filler, wherein the disintegrating agent is calcium carboxymethylcellulose, and the lubricant is sodium stearyl fumarate. In the prior art, the repaglinide has characteristics of poor stability, oxygen unstability and hygrothermal unstability. According to the present invention, the calcium carboxymethylcellulose is adopted as the disintegrating agent and the stabilizing agent so as to increase the stability of the tablets, effectively delay repaglinide degradation and ensure drug quality; the sodium stearyl fumarate is adopted as the lubricant, such that the hydrophobicity is weak, the delayed effect is low, and the influence on the repaglinide is low; and the repaglinide common tablets of the present invention have characteristics of rapid disintegration, complete dissolution and good stability, and provide more excellent various indexes compared with the existing repaglinide common tablets.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a common repaglinide tablet and a preparation method thereof. Background technique [0002] Diabetes mellitus is a common metabolic endocrine disease, which is caused by absolute or relative lack of insulin in the human body and is characterized by hyperglycemia. [0003] Drug therapy is the main method of diabetes treatment, mainly including oral hypoglycemic drug therapy and insulin therapy. Among them, chemical drugs play a dominant role in oral hypoglycemic drugs, and oral hypoglycemic drugs can be divided into insulin secretagogues and non-insulin secretagogues according to different mechanisms of action. [0004] Repaglinide is an insulin secretagogue, a non-sulfonylurea hypoglycemic drug, the English name is Repaglinide, and the chemical name is (S)-2-ethoxy-4-[2-[[3-methyl-1- [2-(1-piperidine)phenyl]butyl]amino]-2-oxyethyl]benzoic acid. Repaglinide is white o...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/451A61K47/38A61K47/12A61K47/18A61K47/32A61K47/36A61K47/10A61K47/04A61P3/10A61P5/50
Inventor 吕旭幸周亚健王丽云陈洁冯超敏陈钗萍
Owner ZHEJIANG YATAI PHARMA
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