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Sertaconazole nitrate suppository and preparation method thereof

A technology of sertaconazole nitrate and conazole suppository, applied in the field of medicine, can solve problems such as low stability of sertaconazole nitrate suppository, increased cost, influence on the appearance of suppository and the like

Active Publication Date: 2021-05-14
HAINAN HAISHEN TONGZHOU PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, because sertaconazole nitrate is difficult to dissolve in water, in order to increase the hydrophilicity of sertaconazole nitrate suppositories and promote the release of drugs, in addition to choosing sertaconazole nitrate In addition to the matrix with good azole compatibility, it is often necessary to add different stabilizers, buffers and other excipients to effectively ensure the sustained release of the drug, resulting in increased costs, affecting the appearance of the suppository, and easily reducing the stability of the sertaconazole nitrate suppository

Method used

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  • Sertaconazole nitrate suppository and preparation method thereof
  • Sertaconazole nitrate suppository and preparation method thereof
  • Sertaconazole nitrate suppository and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1-3

[0026] Sertaconazole nitrate suppository, according to the ratio of parts by weight, includes the raw material formula in the following table:

[0027] Component / g Example 1 Example 2 Example 3 Sertaconazole Nitrate 22.5 25 27.5 glycerin 2 3 4.5 Polysorbate 80 1 2 1 Laurocaprazine 2 3 5 Semi-synthetic fatty acid glycerides 166 169 170

[0028] The preparation method of above-mentioned sertaconazole nitrate suppository comprises the following steps:

[0029] Step 1: Grinding sertaconazole nitrate into fine powder, passing all through a 100-mesh sieve to obtain sertaconazole nitrate powder;

[0030] Step 2: Weigh and mix semi-synthetic fatty acid glycerides, glycerin, laurocapram and polysorbate 80 in proportion, and heat, melt and mix in a water bath at 45°C to obtain a mixed matrix;

[0031] Step 3: The sertaconazole nitrate powder is evenly dispersed in the mixed matrix, and ground for 1 hour, and mixed to obtain a s...

Embodiment 4

[0034] Sertaconazole nitrate suppository, including 25g of sertaconazole nitrate, 4g of glycerin, 802g of polysorbate, 4g of laurocapram and 168g of semi-synthetic fatty acid glyceride.

[0035] Its preparation method comprises the following steps:

[0036] Step 1: Grinding sertaconazole nitrate into fine powder, passing all through a 100-mesh sieve to obtain sertaconazole nitrate powder;

[0037] Step 2: Weigh semi-synthetic fatty acid glycerides, glycerin, laurocapram and polysorbate 80 respectively in proportion, first mix 80% of the quality of laurocapram and polysorbate 80 in a water bath at 60°C and heat, Stir and mix at 600r / min to obtain an organic mixture; then heat the remaining amount of laurocapram, semi-synthetic fatty acid glycerides, and glycerin in a water bath at 35°C, and stir and mix at 350r / min to obtain a matrix premix; finally The matrix premix and the organic mixture were heated and mixed at a constant temperature of 45°C under 850 r / min magnetic stirri...

Embodiment 5

[0041] The present embodiment is identical with each component consumption in embodiment 4, but preparation method is as follows:

[0042] Step 1: Grinding sertaconazole nitrate into fine powder, passing all through a 100-mesh sieve to obtain sertaconazole nitrate powder;

[0043] Step 2: Weigh semi-synthetic fatty acid glycerides, glycerin, laurocapram and polysorbate 80 respectively in proportion, first mix 80% of the quality of laurocapram and polysorbate 80 in a water bath at 60°C and heat, Stir and mix at 600r / min to obtain an organic mixture; then heat the remaining amount of laurocapram, semi-synthetic fatty acid glycerides, and glycerin in a water bath at 35°C, and stir and mix at 350r / min to obtain a matrix premix; finally The matrix pre-mixture and the organic mixture were heated and mixed at a constant temperature of 40°C under 850 r / min magnetic stirring, and kept warm for 5 minutes to obtain a mixed matrix;

[0044] Step 3: Keeping the temperature of the mixed ma...

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Abstract

The invention provides a sertaconazole nitrate suppository and a preparation method thereof. The sertaconazole nitrate suppository is prepared from, by weight, 22.5 parts to 27.5 parts of sertaconazole nitrate, 2 parts to 4.5 parts of glycerinum, 1 part to 2 parts of polysorbate 80, 2 parts to 5 parts of laurocapram and 166 parts to 170 parts of semi-synthetic fatty glyceride. The prepared sertaconazole nitrate suppository is good in drug release stability, small in irritation, high in drug stability and shortened in melting time limit; compared with compatibility of traditional auxiliary materials and sertaconazole nitrate, the variety of auxiliary materials of sertaconazole nitrate suppository is simple, and the use of auxiliary materials such as a stabilizer and a buffering agent is reduce; and cost is low, an appearance color is stable, the surface of the suppository is smooth, and the glossiness of the suppository is good.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a sertaconazole nitrate suppository and a preparation method thereof. Background technique [0002] Sertaconazole nitrate is a new, broad-spectrum, highly effective topical antifungal agent, and its dosage forms include vaginal suppositories, emulsions, vaginal creams, gels, solutions, and powders. Sertaconazole nitrate has quick onset, strong effect and low recurrence rate against Candida, and has good clinical curative effect in the treatment of seborrheic dermatitis, atopic dermatitis and other diseases, and has broad clinical application prospects. [0003] At present, there are more women suffering from vaginal Candida albicans infection, fewer types of clinical medication, and a higher recurrence rate. Sertaconazole nitrate is quite sensitive to Candida albicans. Sertaconazole nitrate suppositories are suitable for vaginal external use for gynecological diseases. , the c...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K47/14A61K47/10A61K47/22A61K47/26A61K31/4178A61P31/10A61P15/02
CPCA61K9/025A61K9/0034A61K47/14A61K47/10A61K47/22A61K47/26A61K31/4178A61P31/10A61P15/02
Inventor 韦家华刘玉
Owner HAINAN HAISHEN TONGZHOU PHARM CO LTD
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