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Pazufloxacin mesylate tablet and preparation method and detection method thereof

A technology of pazufloxacin mesylate and a detection method, applied in the field of medicine, can solve the problems of affecting the appearance of tablets, abrasion of tablet edges, difficulty in granulation and the like, and achieve the effects of beautiful appearance, high safety and definite curative effect

Active Publication Date: 2013-04-24
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Pazufloxacin mesylate tablet is prone to pilling and granulation is difficult during the granulation process, and the edge of the compressed tablet is severely worn during the coating process, which affects the appearance of the tablet

Method used

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  • Pazufloxacin mesylate tablet and preparation method and detection method thereof
  • Pazufloxacin mesylate tablet and preparation method and detection method thereof
  • Pazufloxacin mesylate tablet and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0186] Pazufloxacin Mesylate 260g

[0187] Sodium carboxymethyl starch 5g

[0188] Starch 20g

[0189] Lactose 75g

[0190] 5% polyvinylpyrrolidone K30 in 75% ethanol solution 40ml

[0191] Magnesium Stearate 3.6g

[0192] Opadry II 10.5g

[0193] Makes 1000 pieces

[0194] Preparation method: pass the raw and auxiliary materials through 80-mesh sieve respectively, and set aside. Put pazufloxacin mesylate, sodium carboxymethyl starch, starch, and lactose in high-efficiency wet mixing granulation, after mixing evenly, add 5% polyvinylpyrrolidone K30 in 75% ethanol solution to make soft material, 20 mesh sieve Granulate, boil and dry at 60°C, and granulate with a 20-mesh sieve. Add magnesium stearate to the dry granules, mix evenly; measure the content of the main ingredient in the dry granules, determine the tablet weight, compress into tablets, and coat to obtain.

[0195] Detection method:

[0196] Check: Dextroisomer is measured according to high performance liquid ...

Embodiment 2

[0205]Pazufloxacin Mesylate 210g

[0206] Sodium carboxymethyl starch 9g

[0207] Starch 10g

[0208] Lactose 70g

[0209] 5% polyvinylpyrrolidone K30 in 75% ethanol solution 15ml

[0210] Magnesium Stearate 2g

[0211] Opadry II 4g

[0212] Makes 1000 pieces

[0213] Preparation method: pass the raw and auxiliary materials through 80-mesh sieve respectively, and set aside. Put pazufloxacin mesylate, sodium carboxymethyl starch, starch, and lactose in high-efficiency wet mixing granulation, after mixing evenly, add 5% polyvinylpyrrolidone K30 in 75% ethanol solution to make soft material, 20 mesh sieve Granulate, boil and dry at 60°C, and granulate with a 20-mesh sieve. Add magnesium stearate to the dry granules, mix evenly; measure the content of the main ingredient in the dry granules, determine the tablet weight, compress into tablets, and coat to obtain.

Embodiment 3

[0215] Pazufloxacin Mesylate 290g

[0216] Sodium carboxymethyl starch 2g

[0217] Starch 30g

[0218] Lactose 90g

[0219] 5% polyvinylpyrrolidone K30 in 75% ethanol solution 70ml

[0220] Magnesium Stearate 7g

[0221] Opadry II 18g

[0222] Makes 1000 pieces

[0223] Preparation method: pass the raw and auxiliary materials through 80-mesh sieve respectively, and set aside. Put pazufloxacin mesylate, sodium carboxymethyl starch, starch, and lactose in high-efficiency wet mixing granulation, after mixing evenly, add 5% polyvinylpyrrolidone K30 in 75% ethanol solution to make soft material, 20 mesh sieve Granulate, boil and dry at 60°C, and granulate with a 20-mesh sieve. Add magnesium stearate to the dry granules, mix evenly; measure the content of the main ingredient in the dry granules, determine the tablet weight, compress into tablets, and coat to obtain.

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Abstract

The invention relates to a pazufloxacin mesylate tablet and a preparation method and a detection method thereof, which belong to the technical field of medicines. A medicinal oral tablet with high dissolvability and high stability is prepared by the following steps of: screening the formula components of the pazufloxacin mesylate tablet; and selecting suitable adhesives and adopting specific coating materials. Clinical trials show that the pazufloxacin mesylate tablet has an exact curative effect, a few side effects and high safety.

Description

technical field [0001] The invention relates to a pazufloxacin mesylate tablet, a preparation method and a detection method thereof, and belongs to the technical field of medicine. Background technique [0002] Pazufloxacin belongs to the fourth generation of quinolone anti-infective drugs. It was first researched and developed by Toyama Chemical Company in Japan. It successfully introduced aminocyclopropyl group into the 7th position of its molecular structure, and its side effects are significantly lower than those of similar varieties. Taking it with theophylline does not affect the metabolism of theophylline. This product is well absorbed when taken orally, and has a high blood concentration. It distributes well in the inflammatory parts of the lung tissue and in the eyes, and is mainly excreted in the urine. Therefore, it has a high curative effect on various infectious diseases, especially for respiratory tract infections and surgical infections. Such as biliary tract...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/5383A61K47/38A61P31/04G01N30/02
Inventor 曹相林李海冰高万峰吴王民
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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