Nifuratel-nysfungin soft capsule suppository and preparation method thereof

A technology of nifuratel and nystatin, which is applied in suppository delivery, antifungal agents, and pharmaceutical formulations, and can solve problems such as difficult separation, difficult purification, and easy explosion

Active Publication Date: 2014-02-26
四川摩尔生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

This means that there are serious environmental problems in the production process, such as malodorous gas, malodorous waste residue, dizziness and headache, nausea and vomiting, explosive substances, difficult to separate, difficult to purify, etc.

Method used

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  • Nifuratel-nysfungin soft capsule suppository and preparation method thereof

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Embodiment

[0025] Step a, weighing raw materials according to the prescription amount;

[0026] According to an embodiment of the present application, the formula of nifuratel-nystatin soft capsule suppository includes 500 mg of nifuratel, 200,000 IU of nystatin, 8 mg of promestriene, 25 mg of carbomer, 700 mg of glycerin, paraben Ester 6mg, triethanolamine 294mg, ethanol 800mg, water 7.5g;

[0027] Step b, preparing the medicinal liquid, uniformly mixing nifuratel, nystatin and promestriene to obtain the mixture; the preparation process of the medicinal liquid is completed at a temperature of 20-24°C and a relative humidity of 35%;

[0028] Step c, preparing a gel matrix, dissolving the aqueous gel matrix in water to form a matrix solution; dissolving the glycerol in water and mixing it with the matrix solution, adding ethylparaben and triethanolamine to obtain a gel matrix;

[0029] Step d, prepare nifuratel-nystatin sol, dissolve the mixture in ethanol, add the remaining amount of wa...

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Abstract

The invention discloses a nifuratel-nysfungin soft capsule suppository. The nifuratel-nysfungin soft capsule suppository comprises 500mg of nifuratel, 200000IU of nysfungin, 8mg of promestriene, 25mg of carbomer, 700mg of glycerinum, 6mg of ethylparaben, 294mg of triethanolamine, 800mg of ethyl alcohol and 7.5g of water. The invention also discloses a preparation method of the nifuratel-nysfungin soft capsule suppository. The nifuratel-nysfungin soft capsule suppository can kill bacteria, mould and trichomonad, effectively protect lactobacillus and promote vaginal flora to restore balance, thus realizing the purpose of 'ecological treatment'; and the soft capsule suppository has both the dosage form characteristic of soft capsule (good stability of capsule core, capsule skin and drug) and local drug delivery characteristic of suppository.

Description

technical field [0001] The invention belongs to the technical field of biomedicine and relates to a vaginal suppository, in particular to a nifuratel-nystatin soft capsule type suppository and a preparation method thereof. Background technique [0002] Nifuratel (Nifuratel) is a broad-spectrum antibacterial drug that belongs to the class of furazolidone (this class of drugs also includes nitrofurazone, furadantin, and furazolidone). Nifuratel was developed and marketed by Poli Industria Chimica S.p.A in Italy in the 1960s, and has been marketed and used in more than 20 countries around the world for more than 30 years. Nifuratel + Nystatin vaginal suppositories trade name Complex. In 1997 under the trade name later renamed For domestic sales, the registration number is X970408, X20010224. The drug has more than 30 years of clinical experience and has been used in China for nearly seven years. Since the late 1990s, there have been research reports on nifuratel almost...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/02A61P15/02A61P31/04A61P31/10A61P33/02A61K31/422A61K31/565
Inventor 李智勇
Owner 四川摩尔生物制药有限公司
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