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Preparation method of epalrestat dispersible tablet

A technology of epalrestat and dispersible tablets, which is applied in the field of preparation of epalrestat dispersible tablets, can solve problems such as easy energy consumption, unfavorable large-scale production, and increased costs, so as to reduce process operation steps, reduce input costs, and save energy effect

Inactive Publication Date: 2017-01-04
CHENGDU BAOKE BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] When the existing epalrestat dispersible tablets are prepared, the raw materials are mixed with auxiliary materials, after the soft material is made, they are evenly dried, and then crushed and then granulated with an adhesive, and dried; two-step mixing and two-step drying, the process is cumbersome and unfavorable for large-scale production. Production, and easy to consume energy to increase costs

Method used

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  • Preparation method of epalrestat dispersible tablet
  • Preparation method of epalrestat dispersible tablet
  • Preparation method of epalrestat dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The selection test of embodiment 1 epalrestat dissolving solvent

[0025] Take about 50 mg of the raw materials and put them in a beaker, gradually add ethanol solutions of different concentrations (50%, 75%, 95%), observe while shaking until the solution is clear, and weigh the amount of solvent added. According to the amount of different ethanol concentrations, 150 mg of mixed auxiliary materials were used to make soft materials, and the humidity of the soft materials was observed, and sieved with a 20-mesh sieve. The results are shown in Table 1.

[0026] Table 1 The selection and investigation results of the main ingredient dissolving solvent

[0027]

[0028] Results: The above-mentioned ethanol solutions with different concentrations can dissolve 50mg of raw materials well under a certain amount, have a good wetting effect on 150mg, and have good formability on the material particles. It is confirmed that the granulation solvent of this product uses 50-95% etha...

experiment example 2

[0030] The prescription of epalrestat tablets consists of the ingredients shown in Table 2.

[0031] Table 2 Prescription of Epalrestat Tablets

[0032]

[0033] The preparation method of above-mentioned epalrestat dispersible tablet is as follows:

[0034] Preparation Process:

[0035] 1. Dissolve the prescribed amount of epalrestat and povidone ultrasonically in about 60g of 75% ethanol solution at the same time, as the adhesive containing the main drug, the adhesive is colorless and transparent, without lumps and bubbles .

[0036] 2. Take the prescribed amount of sodium carboxymethyl starch and pregelatinized starch and mix them through a 100-mesh sieve for 3 times.

[0037] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material, granulate with a 20-mesh sieve, and dry in an oven at 60°C (moisture content 1-3%).

[0038] 4. The granules are passed through a 24-mesh sieve for granulation, and magnesium stearate is added a...

experiment example 3

[0041] The prescription of epalrestat tablets consists of the ingredients shown in Table 3.

[0042] Table 3 Prescription of Epalrestat Tablets

[0043]

[0044] The preparation method of above-mentioned epalrestat dispersible tablet is as follows:

[0045] Preparation Process:

[0046] 1. Dissolve the prescribed amount of epalrestat and hydroxypropyl methylcellulose in about 85g of

[0047] In 50% ethanol solution, as the adhesive containing the main drug, the adhesive is colorless and transparent without lumps and bubbles.

[0048] 2. Take the prescribed amount of microcrystalline cellulose and cross-linked polyvinylpyrrolidone and mix them through a 100-mesh sieve for 3 times.

[0049] 3. Add the binder containing the main ingredient to the mixture in step 2, prepare the soft material and granulate it with a 20-mesh sieve, and dry it in an oven at 40°C (moisture content 1-3%).

[0050] 4. The granules are passed through a 24-mesh sieve for granulation, and magnesium ...

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Abstract

The invention provides a preparation method of an epalrestat dispersible tablet. The method comprises the following steps: a, weighing raw materials and auxiliary materials according to a weight ratio, wherein the raw materials and auxiliary materials comprise 15-65 parts of epalrestat, 20-150 parts of a filling agent, 5-10 parts of a disintegrating agent, 1-10 parts of an adhesive, and 1-3 parts of a lubricant; b, dissolving epalrestat and the disintegrating agent in ethanol of 50-95% to prepare a drug-containing adhesive; c, taking a mixture of the filling agent, the lubricant and the adhesive for sieving and mixing; d, adding the drug-containing adhesive obtained in the step b into the mixture prepared in the step c, and performing granulation, drying, size grading, whole blending, and tabletting to prepare the tablet. Through the preparation method, the uniformity of the drug content is ensured, and micronization of raw materials for particle size control is not required. Dissolution of indissolvable drugs is improved, and technological operation steps are reduced through co-dissolution. The energy is saved, and the cost is reduced.

Description

technical field [0001] The invention relates to a preparation method of epalrestat dispersible tablets, belonging to the field of pharmaceutical preparations. Background technique [0002] Epalrestat is a reversible non-competitive inhibitor of aldose reductase, which has selective inhibitory effect on aldose reductase. Clinical studies have shown that epalrestat can inhibit the accumulation of sorbitol in red blood cells in patients with diabetic peripheral neuropathy, and can improve the subjective symptoms and neurological dysfunction of patients compared with the control group. Animal experiments have shown that epalrestat can significantly inhibit the accumulation of sorbitol in the sciatic nerve, red blood cells, and retina of diabetic model rats, and improve the motor nerve conduction velocity and autonomic nervous function; in terms of neuromorphology, epalrestat can improve the axis Abnormal outburst flow can increase the density of myelinated nerve fibers in the s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/426A61P3/10A61P25/02
Inventor 陈立春
Owner CHENGDU BAOKE BIOTECH
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