Nifuratel film-coated tablet and preparation method thereof
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A nifuratel tablet core and nifuratel technology are applied in directions such as pharmaceutical formulations, drug delivery, sexually transmitted diseases, etc., and can solve problems such as instability, light sensitivity, poor stability, etc., so as to achieve control of production costs, easy to get effect
Inactive Publication Date: 2014-10-01
BEIJING SUNHO PHARMA
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However, the nifuratel bulk drug is unstable in acidic solution and extremely sensitive to light
The tablet of this liposome is not protected from light, so the stability of this dosage form is not good
Method used
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Embodiment 1
[0054] Nifuratel…………………… 200g
[0055] Lactose………………………44g
[0056] Microcrystalline cellulose………………40g
[0057] Sodium croscarmellose......8g
[0058] 4% hypromellose solution... 145g
[0059] Silicon dioxide…………………… 1.5g
[0060] Magnesium stearate…………………… 1.5g
[0061] The nifuratel raw material of prescription quantity is passed through 100 meshes, and lactose, microcrystalline cellulose are passed through 80 meshes sieves, are mixed with the method for increasing in equal amounts, crossed 60 meshes sieves three times;
[0062] Weigh the prescribed amount of purified water and heat it to 70-80°C, add hypromellose, stir and dissolve evenly, then add the prescribed amount of 95% ethanol to make a binder, and add it to the sieved material Granulation.
[0063] Preheat the coating pan first, put the compressed plain tablets in the coating pan, the concentration of the coating solution is 6% to 7%, the weight gain of the coating is 3% to 4%, the air inlet temperature is 5...
Embodiment 2
[0065] Nifuratel…………………… 200g
[0066] Lactose………………………40g
[0067] Microcrystalline cellulose………………40g
[0068]4% hypromellose solution... 144g
[0069] Sodium croscarmellose... 12g
[0070] Silicon dioxide…………………… 1.5g
[0071] Magnesium stearate…………………… 1.5g
[0072] The preparation method is the same as in Example 1.
Embodiment 3
[0074] Nifuratel…………………… 200g
[0075] Lactose………………………48g
[0076] Microcrystalline cellulose…………………37.2g
[0077] 4% hypromellose solution…………142g
[0078] Sodium croscarmellose…………8g
[0079] Silicon dioxide……………………… 0.9g
[0080] Magnesium stearate……………………… 0.9g
[0081] The preparation method is the same as in Example 1.
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Abstract
The invention relates to a solid preparation of nifuratel, particularly relates to a nifuratel film-coated tablet and a preparation method thereof and belongs to the field of pharmaceutic preparations. The tablet core is composed of the following components in parts by weight: 200 parts of nifuratel, 35-95 parts of a thinner, 6-8 parts of a disintegrating agent, 0.9-1.5 parts of a flow agent, 0.9-1.5 parts of a lubricating agent and a proper amount of an adhesion agent, wherein the optimal nifuratel film-coated tablet is composed of the following components in parts by weight: 200 parts of nifuratel, 40-50 parts of lactose, 35-45 parts of microcrystalline cellulose, proper amount of 5 percent of a HPMC (Hydroxy propyl methyl cellulose) aqueous solution, 6-8 parts of crosslinking hydroxyl methyl cellulose sodium, 0.9-1.5 parts of silicon dioxide and 0.9-1.5 parts of magnesium stearate. According to the film-coated tablet, an LE yellow coating agent is used, and a coating solution is prepared by using 75 percent of ethanol and water. The nifuratel film-coated tablet has good in-vitro solubleness and the surface of the coating is glossy.
Description
technical field [0001] The invention relates to a solid preparation of nifuratel, in particular to a nifuratel film-coated tablet and a preparation method thereof, belonging to the field of pharmaceutical preparations. technical background [0002] Nifuratel (Nifuratel), its chemical name is: 5-[(methylthio)methyl]-3-[(5-nitrofuryl methylene)amino]-2-oxazolidinone, molecular formula: C 10 h 11 N 3 o 5 S, molecular weight: 285.28. The structural formula is as follows: [0003] [0004] Nifuratel is a nitrofuran derivative and is a broad-spectrum antibiotic, especially for common pathogens of gynecological infections such as Gram-positive and negative bacteria, trichomonas, mold, chlamydia and mycoplasma. Among them, Nifuratel showed antibacterial activity against Gram-positive aerobic bacteria (β-hemolytic streptococcus, Staphylococcus aureus, Staphylococcus epidermidis). In vitro experiments showed that nifuratel was weakly inhibitory against Escherichia coli (but ...
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