Nifuratel-nystatin soft capsule-type suppository and preparation method thereof

A technology of nifuratel and nystatin, which is applied in the field of biomedicine, can solve the problems of normal vaginal flora imbalance, low bioavailability, and poor relative effect, and achieves small drug side effects, simple preparation method, and high drug efficacy Effect

Inactive Publication Date: 2018-11-23
NANJING NANDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the prior art, there are many drugs for treating gynecological inflammation, and many drugs can kill or inhibit single or multiple pathogenic bacteria, but at the same time also inhibit the growth of normal lactobacillus, causing vaginal normal flora imbalance, adverse reactions More, relatively poor effect, low bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A nifuratel-nystatin soft capsule suppository, comprising compressed capsules and nifuratel-nystatin sol, wherein the nifuratel-nystatin sol is composed of the following components by weight: nifuratel-nystatin 50 parts of furatel, 4 parts of nystatin, 3 parts of carbomer, 2 parts of ethyl paraben, 60 parts of glycerin, 80 parts of ethanol, 25 parts of pH buffer solution, 750 parts of medicinal pure water.

[0031] Specifically, the pH value of the nifuratel-nystatin sol is 4.0.

[0032] Specifically, the pH buffer is an acetic acid-sodium acetate buffer with pH=4.0.

[0033] The preparation method of above-mentioned nifuratel-nystatin soft capsule type suppository comprises the steps:

[0034] S1 Prepare raw materials: prepare according to the above weight parts: 50 parts of nifuratel, 4 parts of nystatin, 3 parts of carbomer, 2 parts of ethylparaben, 60 parts of glycerin, 80 parts of ethanol, 25 parts of pH buffer , 750 parts of medicinal pure water;

[0035] S2 pr...

Embodiment 2

[0045] A nifuratel-nystatin soft capsule suppository, comprising compressed capsules and nifuratel-nystatin sol, wherein the nifuratel-nystatin sol is composed of the following components by weight: nifuratel-nystatin 40 parts of furatel, 3 parts of nystatin, 2 parts of carbomer, 1 part of ethyl paraben, 50 parts of glycerin, 70 parts of ethanol, 20 parts of pH buffer solution, and 700 parts of medicinal pure water.

[0046] Specifically, the pH value of the nifuratel-nystatin sol is 5.0.

[0047] Specifically, the pH buffer is an acetic acid-sodium acetate buffer with pH=4.0.

[0048]The preparation method of above-mentioned nifuratel-nystatin soft capsule type suppository comprises the steps:

[0049] S1 Prepare raw materials: prepare according to the above weight parts: 40 parts of nifuratel, 3 parts of nystatin, 2 parts of carbomer, 1 part of ethylparaben, 50 parts of glycerin, 70 parts of ethanol, 20 parts of pH buffer , 700 parts of medicinal pure water;

[0050] S2 p...

Embodiment 3

[0060] A nifuratel-nystatin soft capsule suppository, comprising compressed capsules and nifuratel-nystatin sol, wherein the nifuratel-nystatin sol is composed of the following components by weight: nifuratel-nystatin 60 parts of furatel, 5 parts of nystatin, 3 parts of carbomer, 2 parts of ethylparaben, 70 parts of glycerin, 100 parts of ethanol, 30 parts of pH buffer solution, and 800 parts of medicinal pure water.

[0061] Specifically, the pH value of the nifuratel-nystatin sol is 5.5.

[0062] Specifically, the pH buffer is an acetic acid-sodium acetate buffer with pH=4.0.

[0063] The preparation method of above-mentioned nifuratel-nystatin soft capsule type suppository comprises the steps:

[0064] S1 Prepare raw materials: prepare according to the above weight parts: 60 parts of nifuratel, 5 parts of nystatin, 3 parts of carbomer, 2 parts of ethylparaben, 70 parts of glycerin, 100 parts of ethanol, 30 parts of pH buffer , 800 parts of medicinal pure water;

[0065] ...

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Abstract

The invention relates to a nifuratel-nystatin soft capsule-type suppository and a preparation method thereof. Nifuratel-nystatin sol in the nifuratel-nystatin soft capsule-type suppository is preparedfrom the following components in parts by weight: 40-60 parts of nifuratel, 3-5 parts of nystatin, 2-3 parts of carbomer, 1-2 parts of ethylparaben, 50-70 parts of glycerinum, 70-100 parts of ethyl alcohol, 20-30 parts of pH buffer liquid and 700-800 parts of medical pure water. The preparation method comprises the following steps of 1, raw material preparation; 2, liquid medicine preparation, wherein the nifuratel and the nystatin are mixed evenly in a sterile environment, then through a sterile filtering system, sterile filtering is conducted, and then micro-pore filtering is conducted, sothat a liquid medicine is obtained for later use; 3, gel matrix preparation; 4, nifuratel-nystatin sol preparation; 5, capsule pressing; 6, soft capsule-type suppository preparation. The nifuratel-nystatin soft capsule-type suppository and the preparation method thereof have the advantages that body hormone secretion is not affected, the sterilization effect is good, and the preparation method issimple.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a nifuratel-nystatin soft capsule suppository and a preparation method thereof. Background technique [0002] Nifuratel is effective against bacteria, trichomonas and candida that cause genital infections in women. This product mainly inhibits the growth of bacteria by interfering with its enzyme system, it is difficult to pass through the placenta, and has no teratogenic effect. Nifuratel is rapidly absorbed after oral administration. The peak blood concentration can be reached within 2 hours, and there are reports of high concentrations in saliva and vaginal secretions. The half-life is 2.75 hours. Nifuratel is also metabolized very rapidly, and most of nifuratel is excreted through the kidneys after oral administration. Excreted in urine along with two active metabolites, parent drug and metabolites are also excreted in milk. [0003] Nifuratel is a nitrofuran derivat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K9/48A61K31/7048A61P15/00A61P31/04A61P31/10A61P33/02A61K31/422
CPCA61K9/02A61K9/4866A61K31/422A61K31/7048A61P15/00A61P31/04A61P31/10A61P33/02A61K2300/00
Inventor 李雅
Owner NANJING NANDA PHARMA
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