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Levofloxacin lactate dispersible tablet and preparation method thereof

A technology of levofloxacin and dispersible tablets, which is applied in the field of levofloxacin lactate dispersible tablets and its preparation, and can solve the problem of high requirements for excipients

Active Publication Date: 2019-05-10
HAINAN JINXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For the sake of cost saving, manufacturers often need to reduce the amount of excipients as much as possible under the premise of ensuring product properties, but levofloxacin lactic acid dispersible tablets have high requirements for excipients. stable prescription

Method used

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  • Levofloxacin lactate dispersible tablet and preparation method thereof
  • Levofloxacin lactate dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A dispersible tablet of levofloxacin lactate, comprising the following components by weight: 100 parts of levofloxacin lactate, 40 parts of microcrystalline cellulose, 20 parts of sodium starch glycolate, 38 parts of starch, 1 part of micronized silica gel, 2 parts of magnesium stearate and mass 10 parts ethanol water with a fraction of 65%;

[0025] The starch is hydroxypropyl starch;

[0026] The micro-powder silica gel is processed by the following method: mixing the micro-powder silica gel with xylene, stirring for 1 hour, raising the temperature to 80° C., adding trimethylchlorosilane, continuing to stir for 1 hour, filtering, washing, and drying.

[0027] The mass ratio of micropowder silica gel to xylene is 1:90.

[0028] The addition amount of trimethylchlorosilane is 2% of the mass of the fine powder silica gel.

[0029] The preparation method of the above-mentioned levofloxacin lactate dispersible tablet includes the following steps:

[0030] (1) Pass levofloxacin lacta...

Embodiment 2

[0033] A dispersible tablet of levofloxacin lactate, comprising the following components by weight: 100 parts of levofloxacin lactate, 45 parts of microcrystalline cellulose, 27 parts of sodium starch glycolate, 42 parts of starch, 2 parts of micronized silica gel, 3 parts of magnesium stearate and mass 20 parts of 70% ethanol water;

[0034] The starch is hydroxypropyl starch;

[0035] The micro-powder silica gel is processed by the following method: mixing the micro-powder silica gel with xylene, stirring for 1.5 hours, heating to 90° C., adding trimethylchlorosilane, continuing to stir for 1.5 hours, filtering, cleaning, and drying.

[0036] The mass ratio of micropowder silica gel to xylene is 1:100.

[0037] The addition amount of trimethylchlorosilane is 3% of the mass of the fine powder silica gel.

[0038] The preparation method of levofloxacin lactate dispersible tablets is the same as in Example 1.

Embodiment 3

[0040] A dispersible tablet of levofloxacin lactate, comprising the following components by weight: 100 parts of levofloxacin lactate, 45 parts of microcrystalline cellulose, 27 parts of sodium starch glycolate, 42 parts of starch, 2 parts of micronized silica gel, 3 parts of magnesium stearate and mass 20 parts ethanol water with a fraction of 60 to 70%;

[0041] The starch is hydroxypropyl starch;

[0042] The micro-powder silica gel is processed by the following method: mixing the micro-powder silica gel with xylene, stirring for 1.5 hours, heating to 90° C., adding trimethylchlorosilane, continuing to stir for 1.5 hours, filtering, cleaning, and drying.

[0043] The mass ratio of micropowder silica gel to xylene is 1:90.

[0044] The addition amount of trimethylchlorosilane is 3% of the mass of the fine powder silica gel.

[0045] The preparation method of the above-mentioned levofloxacin lactate dispersible tablet includes the following steps:

[0046] (1) Take starch, microcrystal...

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Abstract

The invention discloses a levofloxacin lactate dispersible tablet. The dispersible tablet comprises, by weight, 100 parts of levofloxacin lactate, 40-45 parts of microcrystalline cellulose, 20-27 parts of sodium carboxymethyl starch, 38-42 parts of starch, 1-2 parts of micro-powder silica gel, 2-3 parts of magnesium stearate and 10-20 parts of ethanol water with the mass fraction of 60-70%, wherein the starch is hydroxypropyl starch; the micro-powder silica gel is silica gel modified by trimethyl chlorosilane. Part of auxiliary materials are optimized so that the usage quantity of the auxiliary materials can be greatly reduced, related substances, content, dissolution rate, dispersion uniformity and stability of the product are also improved, and therefore the aims of reducing the production cost and improving the product quality are achieved at the same time.

Description

Technical field [0001] The invention relates to a levofloxacin lactate dispersible tablet and a preparation method thereof, and belongs to the technical field of medicine processing. Background technique [0002] Levofloxacin lactate is the lactate of levofloxacin, which is mainly used to treat urinary tract infections and respiratory system infections. Levofloxacin lactate dispersible tablets have the advantages of fast disintegration, high bioavailability, convenient taking, and convenient storage and transportation. They can be swallowed, chewed, sucked or dispersed with water to form a uniform and good-tasting suspension, which is especially suitable for patients to take. Can increase patient compliance. The excipients in the prescription of levofloxacin lactate dispersible tablets account for most of the ingredients, so to a large extent the nature and amount of excipients determine the quality of the product. For cost-saving considerations, producers often need to reduce ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/06A61K47/34A61K31/5383A61P31/04
Inventor 刘全胜刘春燕邢贞凯林祖勰柯克聪陈艳刘建刚
Owner HAINAN JINXING PHARMA
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