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Nifuratel-nysfungin vaginal soft capsule and preparation method thereof

A technology of nifuratel and nystatin, which is applied in the field of medicine, can solve the problems that soft capsules cannot be dissolved well, cannot absorb active ingredients, and superficial mucosal ulcers, so as to prevent mildew, improve drug efficacy, and improve vulva burning effect

Active Publication Date: 2013-12-04
SINOPHARM CHUANKANG PHARMACEUTICAL CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Nystatin is a polyene antifungal drug with strong activity against Candida, so many use the combination of nifuratel and nystatin to treat mixed vaginal infections (Candida, Trichomonas and bacteria) effervescent tablets, suppositories, and soft capsules. Among them, in addition to effectively exerting the effects of nifuratel and nystatin and reducing side effects, an important consideration for suppositories and soft capsules is the use of Comfort of the patient and increase the full contact of the active ingredients with the vagina. At present, many suppositories and soft capsules have relatively large defects in this respect, such as users will have mild vulva burning, and superficial mucosal ulcers are easy to form on the adhesions Or it feels greasy, the soft capsule cannot be dissolved well, and the active ingredients cannot be fully absorbed, which affects the efficacy of the medicine

Method used

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  • Nifuratel-nysfungin vaginal soft capsule and preparation method thereof
  • Nifuratel-nysfungin vaginal soft capsule and preparation method thereof
  • Nifuratel-nysfungin vaginal soft capsule and preparation method thereof

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Effect test

Embodiment 1

[0035] A nifuratel-nystatin vaginal soft capsule, each containing the following components: a nifuratel-nystatin vaginal soft capsule, each containing the following components: nifuratel 400mg, Nystatin 2×10 5 IU, 1100 mg of soybean oil, 1000 mg of gelatin, 500 mg of glycerin, 1100 mg of purified water, 20 mg of titanium dioxide, 6.5 mg of methylparaben, and 1.5 mg of tartrazine.

[0036] The preparation method of above-mentioned nifuratel-nystatin vaginal soft capsule comprises the following steps:

[0037] (1) Preparation of rubber solution

[0038] (1) There is a vacuum mixing tank in the glue making room, and the purified water, glycerin, and titanium dioxide are weighed according to the ratio of 1100mg of purified water, 500mg of glycerin, 20mg of titanium dioxide, 6.5mg of methylparaben and 1.5mg of tartrazine in each capsule , methylparaben and tartrazine are placed in the vacuum mixing tank, stirred evenly and the central control mixing tank is heated. Add gelatin a...

Embodiment 2

[0055] A kind of preparation method of nifuratel-nystatin vaginal soft capsule, its step is basically consistent with embodiment one, and its difference is:

[0056] When adding various components, add according to the following ratio in each capsule: Nifuratel 300 mg, Nystatin 4×10 5 IU, soybean oil 1000mg, gelatin 800mg, glycerin 300mg, purified water 600mg, titanium dioxide 10mg, methylparaben 6mg and tartrazine 1.25mg.

[0057] When preparing the rubber liquid, place purified water, glycerin, titanium dioxide, methylparaben and tartrazine in the vacuum mixing tank, stir evenly and heat the central control mixing tank at a temperature of 65°C; The glue in the mixing tank is stirred and vacuumed at the same time, and the vacuum degree is controlled at -0.07Mpa. After 0.5 hours of treatment, the stirring is stopped, and the vacuum is continued for 2 hours; Decrease to zero, set the insulation temperature of the vacuum mixing tank to 50°C, let the glue stand in the vacuum mix...

Embodiment 3

[0063] A kind of preparation method of nifuratel-nystatin vaginal soft capsule, its step is basically consistent with embodiment one, and its difference is:

[0064] When adding various components, add according to the following ratio in each capsule: Nifuratel 600mg, Nystatin 4×10 5 IU, Soybean Oil 1200mg, Gelatin 1200mg, Glycerin 700mg, Purified Water 1200mg, Titanium Dioxide 25mg, Methylparaben 7mg and Tartrazine 2.5mg.

[0065] When preparing the rubber liquid, place purified water, glycerin, titanium dioxide, methylparaben and tartrazine in the vacuum mixing tank, stir evenly and heat the centrally controlled mixing tank at 80°C; The glue in the mixing tank is stirred and vacuumed at the same time, and the vacuum degree is controlled at -0.2Mpa. After 1.5 hours of treatment, stop stirring and continue to vacuumize for 3 hours; Decrease to zero, set the heat preservation temperature of the vacuum mixing tank to 60°C, let the glue stand in the vacuum mixing tank with a tem...

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Abstract

The invention provides a nifuratel-nysfungin vaginal soft capsule. One nifuratel-nysfungin vaginal soft capsule comprises the following components by weight: 450 g to 550 g of nifuratel, 1.5*105 IU to 2.5*105 IU of nysfungin, 1000 mg to 1100 mg of soybean oil, 950 mg to 1050 mg of gelatin, 480 mg to 550 mg of glycerinum, 950 mg to 1050 mg of purified water, 20 mg to 30 mg of titanium dioxide, 6 mg to 7 mg of methylparaben, and 1 mg to 1.5 mg of lemon yellow. The preparation method of the soft capsule comprises the following steps: preparing rubber fluid firstly, then preparing drug liquid, and performing the processes such as pelleting, drying, tablet washing and airing, so that the soft capsule is obtained. The nifuratel-nysfungin vaginal soft capsule provided by the invention has effects of effectively inhibiting and killing pathogens and no drug resistance, the rubber is less susceptible to saponification, the nifuratel-nysfungin vaginal soft capsule is easy to disintegrate, the dissolubility of drugs is improved, the drug effect is improved, and the comfortable degree of users is increased.

Description

technical field [0001] The invention relates to the field of medicine, and more specifically refers to a nifuratel-nystatin vaginal soft capsule and a preparation method thereof. Background technique [0002] Vaginal disease is a common disease of women. At present, medicaments containing nifuratel are often used to treat such diseases. Nifuratel is a nitrofuran derivative with broad-spectrum antimicrobial effects. It is effective against trichomonas, bacteria, Candida albicans, etc. are active, and its chemical formula is [0003] [0004] Nystatin is a polyene antifungal drug with strong activity against Candida, so many use the combination of nifuratel and nystatin to treat mixed vaginal infections (Candida, Trichomonas and bacteria) effervescent tablets, suppositories, and soft capsules. Among them, in addition to effectively exerting the effects of nifuratel and nystatin and reducing side effects, an important consideration for suppositories and soft capsules is the...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K9/48A61K47/42A61P15/02A61P33/02A61P31/04A61K31/422
Inventor 翟元明邵方伟伍忠文王永夏陈德丽许日泉
Owner SINOPHARM CHUANKANG PHARMACEUTICAL CO LTD
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