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A three-dimensional nystatin suppository and its preparation method

A three-dimensional nystatin suppository and nystatin technology, applied in the field of medicine, can solve the problems of unstable light and air, affecting the quality of medicines, prone to oxidation, etc. Effect

Active Publication Date: 2019-09-03
武汉人福药业有限责任公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] It can be seen that nystatin has hygroscopicity and is unstable to light and air, while vitamin E and vitamin A are unstable under light and high temperature environments, and are prone to oxidation, which affects the quality of drugs.
At present, there is no research on the stability of three-dimensional nystatin suppository

Method used

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  • A three-dimensional nystatin suppository and its preparation method
  • A three-dimensional nystatin suppository and its preparation method
  • A three-dimensional nystatin suppository and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1 3

[0030] The preparation of embodiment 1 three-dimensional nystatin suppository

[0031] Prescription 1:

[0032]

[0033] Prescription 2:

[0034]

[0035] Prescription 3:

[0036]

[0037] Preparation:

[0038] (1) Preparation of emulsion: add distilled water after weighing gelatin, make it fully dissolve in 40 ℃ water bath, weigh Arabic gum again, add distilled water, make it fully dissolve under the same condition, then these two solutions are mixed evenly, Then add the raw materials, and then use a high-shear emulsifying homogenizer to continue emulsifying for 30 minutes under the condition of 1000r / m under the condition of avoiding light, so that the mixture is fully mixed and uniform to form a uniform emulsion. The concentration of the gelatin-gum arabic emulsion is 5%.

[0039] (2) Complex coacervation reaction: Pour the emulsion into distilled water preheated to 40° C. for dilution, adjust the pH between 4.0 and 4.6 with 10% acetic acid solution, and coagul...

Embodiment 2 3

[0041] The preparation of embodiment 2 three-dimensional nystatin suppository comparison example

[0042]

[0043] Weigh the semi-synthetic fatty acid glyceride, melt it to about 3 / 4 at 65°C, stop heating, continue to stir, wait until the temperature drops to 60°C, add nystatin, vitamin E, vitamin A and vitamin D2 to the melted In the matrix, after stirring evenly, the temperature of the matrix before injection is about 50°C, inject it into the plug mold that has been evenly coated with lubricating oil, cool for 30 minutes, and scrape off the overflowing part to obtain the finished suppository.

Embodiment 3 3

[0044] The stability of embodiment 3 three-dimensional nystatin suppositories

[0045] Take the three-dimensional nystatin suppository and place it in a hygrostat with a relative humidity of 75% ± 5% and a relative humidity of 90% ± 5%, and place it at room temperature for 10 days, take samples on the 0th day, 5th day and 10th day, and investigate its content , the test results are shown in Table 1. The test results show that the three-dimensional nystatin suppository of the present invention and the comparative example are all unstable under the condition of relative humidity of 90%±5%, and the comparative example is unstable under the condition of relative humidity of 75%±5%, while the three-dimensional nystatin suppository of the present invention is unstable. The stability of Sushuan is obviously better than that of the comparative example, and the stability of prescription 2 is the best.

[0046] Take the three-dimensional nystatin suppository in a light box with an il...

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Abstract

The invention provides a three-vitamins and nysfungin suppository and its preparation method. The three-vitamins and nysfungin suppository is composed of nysfungin, vitamins E, vitamins A, vitamins D2, gelatin, Arabic gum and a matrix. The three-vitamins and nysfungin suppository is stable in quality, better in efficacy, convenient to carry and suitable for industrial production, and the production process is simple and easy to operate.

Description

[0001] 1. Technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a three-dimensional nystatin suppository and a preparation method thereof. [0003] 2. Background technology [0004] Three-dimensional nystatin suppository is a compound preparation, which is currently included in the thirteenth volume of "Chemical Medicine Landmark Upgrade National Standard". Its prescription is 200 million units of nystatin, 10 grams of vitamin E, 3 million units of vitamin A, and 2 300,000 units, appropriate amount of matrix, made into 1,000 pieces. Three-dimensional nystatin has a broad-spectrum antibacterial effect. It is mainly used for the treatment of candida vaginitis (mycotic vaginitis). Mold etc. [0005] Nystatin is a polyene antifungal drug, mainly used for the prevention and treatment of skin and mucous membrane candidiasis. Taking different regimens and antibacterial drugs at the same time can inhibit the excessive growth ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61K9/02A61P15/02A61P31/04A61P31/10A61P17/04A61P15/00A61P29/00A61K31/07A61K31/355A61K31/592
Inventor 郭芬刘红华唐维邓霞飞方智陈诗陈盛刚
Owner 武汉人福药业有限责任公司
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