Vaginal effervesce tablet of ornidazole and its preparation method

A technology of ornidazole and effervescent tablets is applied in the field of ornidazole vaginal effervescent tablet formulation and preparation thereof, and can solve the problems such as swelling, rupture and deformation of effervescent tablets

Active Publication Date: 2008-02-13
NANJING SANHOME PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, it is not easy to control the amount of foaming through conventional preparation methods, and because of the addition of solubilizing ingredients, gas will be generated when it meets water, resulting in expansion, deformation, and rupture of effervescent tablets, so it is easy to deliquesce and deteriorate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The prescription consists of:

[0047] (a) Ornidazole 500mg / tablet

[0048] (b) Sodium bicarbonate 300mg / tablet

[0049] (c) Low-substituted hydroxypropyl cellulose 100mg / tablet

[0050] (d) Sodium lauryl sulfate 3.2mg / tablet

[0051] (e) Microcrystalline cellulose 440mg / tablet

[0052] (f) Tartaric acid 280mg / tablet

[0053] (g) polyethylene glycol 16mg / tablet

[0054] Taking the production of 100 ornidazole vaginal effervescent tablets as an example, the specific preparation method is to grind the raw and auxiliary materials in the prescription respectively through an 80-mesh sieve; weigh the prescription amount of ornidazole, sodium lauryl sulfate, bicarbonate Sodium, 75% of the prescription amount of microcrystalline cellulose, and 80% of the prescription amount of low-substituted hydroxypropyl cellulose are mixed evenly, and the soft material is made of 60% ethanol, granulated with a 14-mesh nylon sieve, and the wet granules are placed in an oven at 60°C Medi...

Embodiment 2

[0056] Check the stability of the product. Ornidazole vaginal effervescent tablets were prepared by the method described in Example 1 and placed to investigate the appearance and foaming amount of the product after 0 days, January, February, June, and December. The results are shown in the table below.

[0057] Table. Stability test of ornidazole vaginal effervescent tablets

[0058] placement time

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PUM

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Abstract

The invention relates to an Ornidazole vaginal effervescent tablet, which comprises 1 weight part of Ornidazole, 0.54-0.66 weight part of sodium hydrogen carbonate, 0.18-0.22 weight part of low substituted methylcellulose propylene glycol ether, 0.0057-0.0070 weight part of sodium dodecylsulfate, 0.79-0.97 weight part of microcrystalline cellulose, organic acid 82% by molar weight of organic acid, 0.028-0.035 weight part of polyethylene glycol.

Description

technical field [0001] The invention relates to an ornidazole vaginal effervescent tablet preparation and a preparation method thereof. Background technique [0002] Ornidazole (CAS 16773-42-5), a nitroimidazole derivative, is a powerful drug against anaerobic bacteria and antiprotozoal infections. It is also a newly developed drug after metronidazole with higher efficacy and shorter treatment course , The third generation of nitroimidazole derivatives with better tolerance and wider distribution in the body. The antimicrobial effect of ornidazole is through the reduction of the nitro group in its molecule to an amino group in an oxygen-free environment, or through the formation of free radicals to interact with cell components, resulting in the death of microorganisms. Studies have found that ornidazole also plays an important role in the anti-broad-spectrum fungal infection (see esp.NO.CN1335132). In vivo and in vitro pharmacodynamic experiments, ornidazole is effective a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4164A61K9/20A61K9/46A61P15/02
Inventor 张仓滕再进
Owner NANJING SANHOME PHARMACEUTICAL CO LTD
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