Preparation method of clarithromycin dispersible tablet

A technology for clarithromycin and dispersible tablets, which is applied in the field of preparation of clarithromycin dispersible tablets, can solve the problems of increasing process operation, high input cost, easy loss of raw materials, etc., and achieves reduction of process operation steps, reduction of input cost and savings 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

Although this method improves the dissolution rate of clarithromycin, it needs special micronization equipment in industrial production to pulverize clarithromycin, and the input cost is high and raw materials are easy to be lost, which increases the process operation process and is difficult to control

Method used

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  • Preparation method of clarithromycin dispersible tablet
  • Preparation method of clarithromycin dispersible tablet
  • Preparation method of clarithromycin dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The selection test of embodiment 1 clarithromycin dissolving solvent

[0026] Take about 200 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 dosage of different ethanol concentrations, 800 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.

[0027] Table 1 The selection and investigation results of the main drug dissolution solvent

[0028]

[0029] Results: The above-mentioned ethanol solutions with different concentrations can dissolve 200 mg of raw materials well under a certain amount, and the amount of solvent has a good wetting effect on 800 mg of auxiliary materials, and it has good formability on material particles. It is determined that the gr...

experiment example 2

[0031] The prescription of clarithromycin tablets consists of the ingredients shown in Table 2.

[0032] Table 2 Prescription of clarithromycin tablets

[0033]

[0034]

[0035] The preparation method of above-mentioned clarithromycin dispersible tablet is as follows:

[0036] Preparation Process:

[0037] 1. Dissolve the prescribed amount of clarithromycin and hydroxypropyl methylcellulose in about 50g of 75% ethanol solution at the same time, and use it as an adhesive containing the main drug. The adhesive is colorless and transparent without lumps Blocks and bubbles.

[0038] 2. Take the prescribed amount of lactose, corn starch, cross-linked polyvinylpyrrolidone, and sodium saccharin and mix them through a 100-mesh sieve for 3 times.

[0039] 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%).

[0040] 4. The granules are passed t...

experiment example 3

[0043] The prescription of clarithromycin tablet consists of the ingredients shown in Table 3.

[0044] Table 3 Prescription of clarithromycin tablets

[0045]

[0046] The preparation method of above-mentioned clarithromycin dispersible tablet is as follows:

[0047] Preparation Process:

[0048] 1. Dissolve prescription amount of clarithromycin and hydroxypropyl cellulose ultrasonically in about 70g of 50% ethanol solution at the same time, as a binder containing the main ingredient, the binder is colorless and transparent, without agglomerates and bubble.

[0049] 2. Take the prescribed amount of lactose, corn starch, croscarmellose sodium, and aspartame and mix them through a 100-mesh sieve for 3 times.

[0050] 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%).

[0051] 4. The granules are passed through a 24-mesh sieve for...

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Abstract

The invention provides a preparation method of a clarithromycin dispersible tablet. The preparation method comprises the following steps: a, weighing the following raw materials and auxiliary materials in parts by weight: 1-5 parts of clarithromycin, 4.7-8.7 parts of a filling agent, 0.5-1.5 parts of a disintegrating agent, 0.05-0.25 part of a lubricating agent, and 0.05-0.1 part of an adhesive; b, dissolving clarithromycin and the disintegrating agent into 50-95% alcohol, thus preparing a medicine-containing adhesive; and c, screening the mixed filling agent, lubricating agent and adhesive by a sieve, and mixing the screened materials; and d, adding the medicine-containing adhesive obtained in the step b into the mixture prepared in the step c, and carrying out pelleting, drying, size stabilizing, mixing and tabletting, thus preparing the tablet. With the adoption of the preparation method of the clarithromycin dispersible tablet, the medicine content uniformity can be guaranteed, the micronization for controlling the grain diameter of the raw materials is not needed, the dissolving out of the indissolvable medicines can be increased, meanwhile, through the co-dissolving, the technological operation steps are reduced, the energies are saved, and the cost is reduced.

Description

technical field [0001] The invention relates to a preparation method of clarithromycin dispersible tablets, belonging to the field of pharmaceutical preparations. Background technique [0002] Clarithromycin is a new macrolide antibiotic similar in structure and antibacterial spectrum to erythromycin, and it is one of the representatives of new varieties of semi-synthetic erythromycin. It can penetrate the cell wall of bacteria and then combine with the new army ribosome 5OS subunit reversibly to produce blocking transpeptide and translocation, which can effectively inhibit the elongation of the chain, reduce the synthesis of RNA-dependent protein, and play a bacteriostatic effect. Its antibacterial activity is more than twice that of erythromycin. Compared with other traditional macrolide antibiotics, the pharmacodynamics and pharmacokinetic properties of clarithromycin have been significantly improved, and it is rapidly absorbed in the gastrointestinal tract after oral ad...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7048A61K47/38A61J3/10
Inventor 陈立春
Owner CHENGDU BAOKE BIOTECH
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