Nifuratel-containing pharmaceutical composition and preparation method thereof

A nifuratel and composition technology, applied in the pharmaceutical composition containing nifuratel and its preparation field, can solve the problems of vaginal soft capsules being unable to disperse, and achieve the effect of overcoming the inability to disperse and increasing the speed

Active Publication Date: 2020-08-21
HAIHE PHARMA WENZHOU
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, the object of the present invention is to provide a pharmaceutical composition containing nifuratel and a preparation method thereof, which overcomes the inability of nifuratel nystatin vaginal soft capsules to disperse during the detection of the melting time limit in the prior art. phenomenon, the pharmaceutical composition prepared by the present invention can be continuously dispersed, has good hydrophilicity, and is easier to uniformly disperse and apply to the vaginal mucosa

Method used

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  • Nifuratel-containing pharmaceutical composition and preparation method thereof
  • Nifuratel-containing pharmaceutical composition and preparation method thereof
  • Nifuratel-containing pharmaceutical composition and preparation method thereof

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preparation example Construction

[0019] The present invention also provides a preparation method of the pharmaceutical composition described in the above technical scheme, comprising: mixing the nifuratel, 50% of the total mass of gelatin for capsules, and purified water to obtain a soft material, and making the soft material Granules are obtained to obtain granules, and the granules are mixed with simethicone AK 1000, 50% of the total mass of gelatin for capsules, and nystatin to obtain a pharmaceutical composition.

[0020] In the present invention, the preparation of the soft material preferably includes: firstly mixing the nifuratel with 50% of the total mass of gelatin for capsules to obtain a mixture, then adding purified water to the mixture and mixing to obtain the soft material. The preparation of the soft material of the present invention can make the nifuratel and the gelatin for capsules fully adhere together, so that the solubility in water is improved.

[0021] In the present invention, the gran...

Embodiment 1

[0034] Mix 1 kg of nifuratel and 0.1 kg of capsule gelatin, add 0.26 kg of purified water, and mix evenly to obtain soft material. Pass the soft material through a 20-mesh sieve for granulation. During the granulation process, the stirring speed is 100r / min, the shearing speed is 200r / min, and the time is 10min. After granulation, dry at 50°C for 2h to obtain The dry matter is passed through a 50-mesh sieve to obtain granules. Mix the granules with 1.8 kg of simethicone AK 1000, 0.1 kg of gelatin for capsules and 0.07 kg of nystatin to obtain a pharmaceutical composition.

Embodiment 2

[0036] Mix 1 kg of nifuratel with 0.15 kg of capsule gelatin, add 0.30 kg of purified water, and mix evenly to obtain soft material. Pass the soft material through a 35-mesh sieve for granulation. During the granulation process, the stirring speed is 300r / min, the shearing speed is 1500r / min, and the time is 4min. After granulation, dry at 60°C for 1.5h. The dry matter is obtained, and the dried matter is passed through a 60-mesh sieve to obtain granules. Mix the granules with 1.6 kg of simethicone AK 1000, 0.15 kg of gelatin for capsules and 0.07 kg of nystatin to obtain a pharmaceutical composition.

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Abstract

The invention provides a pharmaceutical composition containing nifuratel and a preparation method of the pharmaceutical composition, which belongs to the technical field of pharmaceutical preparations, and is prepared from the following components in parts by weight: 1 part of nifuratel, 0.07 part of nystatin, 0.2-0.4 part of gelatin for capsules, 1.6-1.8 parts of dimethicone AK 1000 and 0.26-0.36part of purified water. The nifuratel-containing pharmaceutical composition provided by the invention overcomes the phenomenon that nifuratel nystatin vaginal soft capsules in the prior art cannot bedispersed during melting time limit detection. Experimental results show that when the pharmaceutical composition is subjected to melting time limit detection, the sustainable dispersion hydrophilicity is good, and the melting time limit is obviously superior to that of other similar products.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition containing nifuratel and a preparation method thereof. Background technique [0002] Nifuratel is a nitrofuran derivative with broad-spectrum antimicrobial activity, and is active against trichomonas, bacteria, and Candida albicans. Nystatin is a known fungicidal antibiotic with particular activity against genomycotic fungi. Indeed, a clear positive synergy between the two drugs was detected in the antifungal sense. It can provide a safer effect in the treatment of mixed vaginal infections (Candida, Trichomonas and bacteria), when the pathogen cannot be clearly diagnosed and cannot be diagnosed in time, and when the recurrence of fungal superinfection and other drug treatment is prevented. The molecular formula of nifuratel is C 10 h 11 N 3 o 5 S, the molecular weight is 285.28; the molecular formula of nystatin i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/42A61K47/44A61K31/422A61K31/7048A61P31/10A61P15/02
CPCA61K9/0034A61K47/42A61K47/44A61K31/422A61K31/7048A61P31/10A61P15/02A61K2300/00Y02A50/30
Inventor 李淑君邱欣程书辉王海健
Owner HAIHE PHARMA WENZHOU
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