Secnidazole tablet and its prepn process

A technology of secnidazole tablets and secnidazole, which is applied in the field of medicine, can solve the problems of large therapeutic dose and low melting point, and achieves the effects of high main drug content, low tablet weight and easy swallowing

Inactive Publication Date: 2007-06-06
湖北科益药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because secnidazole has a bitter taste, is slightly soluble in cold water, has a large therapeutic dose (1g-2g per dose), and a low melting point (74-76°C), the prescription and preparation process of its marketed preparations have not been reported in the literature.

Method used

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  • Secnidazole tablet and its prepn process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0010] Embodiment 1 per 1000 dosage

[0011] Secnidazole 266g (in C 7 h 11 N 3 o 3 250g in total)

[0012] Microcrystalline Cellulose 62.85g

[0013] Starch 100g

[0014] Lactose 50g

[0015] Cross-linked polyvinylpyrrolidone 37.25g

[0016] Hypromellose 5.3g

[0017] Talc powder 5.3g

[0018] Magnesium stearate 10.6g

[0019] Preparation method: crush secnidazole and pass through a 30-mesh sieve. Take the prescribed amount of secnidazole, microcrystalline cellulose, starch and lactose, and cross-linked polyvinylpyrrolidone (about half the amount) and mix well. Prepare hypromellose with 50% (V / V) ethanol to make a 2 g / L ethanol solution, add the above mixture to make soft material, granulate with 14 mesh sieve, and drum the granules in a constant temperature oven at 40°C to 45°C Air dry for 5 hours. Sieve through a 14-mesh sieve, add cross-linked polyvinylpyrrolidone (the remaining half of the amount), talcum powder, and magnesium stearate, mix evenly, measure the...

Embodiment 2

[0020] Embodiment 2 per 1000 dosage

[0021] Secnidazole 532g (in C 7 h 11 N 3 o 3 500g in total)

[0022] Microcrystalline Cellulose 50g

[0023] 100g pregelatinized starch

[0024] Lactose 65.8g

[0025] Cross-linked polyvinylpyrrolidone 3.8g

[0026] Hypromellose 0.8g

[0027] Micronized silica gel 3.8g

[0028] Magnesium Stearate 3.8g

[0029] Preparation method: crush secnidazole and pass through a 50-mesh sieve. Weigh secnidazole, microcrystalline cellulose, pregelatinized starch, lactose, and cross-linked polyvinylpyrrolidone (about half the amount) and mix well. Prepare hypromellose with 80% (V / V) ethanol to make 1 g / L ethanol solution, add the above mixture to make soft material, granulate with 24 mesh sieve, and drum the granules in a constant temperature oven at 40°C to 45°C Air dry for 4 hours. Sieve through a 24-mesh sieve for granulation, add cross-linked cross-linked polyvinylpyrrolidone (the remaining half), micropowder silica gel, and magnesium st...

Embodiment 3

[0030] Embodiment 3 per 1000 dosage

[0031] Secnidazole 1064g (in C 7 h 11 N 3 o 3 1000g in total)

[0032] Microcrystalline Cellulose 6g

[0033] Croscarmellose Sodium 70.4g

[0034] Polyvinylpyrrolidone (K30) 29.6g

[0035] Talc powder 6g

[0036] Magnesium Stearate 6g

[0037] Preparation method: crush secnidazole and pass through 80-mesh sieve. Weigh secnidazole, microcrystalline cellulose, and croscarmellose sodium (about half the amount) and mix well. Prepare polyvinylpyrrolidone with 75% (V / V) alcohol to make 20 g / L ethanol solution, add the above mixture to make soft material, granulate with 20 mesh sieve, and dry the granules in a constant temperature oven at 40°C to 45°C 2 hours. Sieve through a 20-mesh sieve, add croscarmellose sodium (the remaining half), mix evenly, measure the content, calculate the weight of the tablet, and compress to obtain the tablet.

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PUM

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Abstract

The secnidazole tablet contains secnidazole 50-90 wt%, microcrystalline cellulose, starch, pre-gelatinized starch and/or lactose 0.5-40 wt%, cross-linked sodium carboxymethyl cellulose and/or cross-linked polyvinyl pyrrolidone 0.5-9 wt%, polyvinyl pyrrolidone or hydroxypropylmethyl cellulose 0.1-2.5 wt%, magnesium stearate 0.5-1 wt%, and talcum powder and/or fine silica gel powder 0.5-1 wt%. The preparation process of the secnidazole tablet includes the steps of mixing the said materials, palletizing and tabletting. The secnidazole tablet has high effective component content, easy swallowing, no bitter taste and fast leaching.

Description

technical field [0001] The invention relates to secnidazole tablets and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Secnidazole is a nitroimidazole drug. Its structure is similar to that of metronidazole, but its antibacterial spectrum is wider than that of metronidazole, and its pharmacokinetic half-life is about twice as long as that of metronidazole. It has the characteristics of long-acting and high selectivity. , mainly used for giardiasis, intestinal amoebic liver disease, urogenital trichomoniasis, bacterial vaginosis and systemic infections caused by anaerobic bacteria, such as anaerobic bacterial infection in abdominal surgery and gynecological surgery, gynecological vagina Anaerobic infection. Secnidazole was developed in the 1960s by the French company Rhona-Poulec Rorer (abbreviated as RPR company), and it is now on the market in the Philippines, Mexico, France, Brazil, Portugal and other countries. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4164A61K9/20A61K47/38A61P31/04A61P33/02
Inventor 吴小玉程天贵游窑生
Owner 湖北科益药业股份有限公司
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