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Secnidazole vaginal expansion suppository and its preparation method and detection method

A vaginal expansion suppository, secnidazole technology, applied in the directions of suppository delivery, pharmaceutical formulations, material testing products, etc., can solve the problems of difficult absorption, low bioavailability, reduced clinical application, etc. Problems, the effect of avoiding secondary infection

Active Publication Date: 2016-10-05
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparations related to secnidazole in the prior art include tablets, injections and suppositories, etc. The tablets and injections generally have the disadvantages of inconvenient use, low dissolution rate of secnidazole, difficult absorption, and low bioavailability and other adverse reactions, while ordinary suppositories are easy to use, but they also have problems such as difficulty in absorption and low bioavailability; at the same time, the liquid medicine is easily excreted from the body, contaminates clothes, and is not easy to clean; the sliver in the suppository does not expand or expand disorderly, Reduce clinical application; Unreliable quality control methods lead to large variations in batch-to-batch content, stability, and melting time limit in the actual production process; active ingredients cannot fully exert their curative effects, etc.

Method used

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  • Secnidazole vaginal expansion suppository and its preparation method and detection method
  • Secnidazole vaginal expansion suppository and its preparation method and detection method
  • Secnidazole vaginal expansion suppository and its preparation method and detection method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099]

[0100] Preparation:

[0101] 1) Preparation of drug-containing matrix:

[0102] a. Take lanolin alcohol and hardened oil and place them in a water bath for heating and melting to obtain a melt;

[0103] b. Mixing secnidazole and the melt of step a evenly to obtain a drug-containing matrix;

[0104] 2) Pour the drug-containing matrix into the suppository membrane, insert a tampon, cool and shape, and make 100 spherical suppositories, each weighing about 4.4g.

Embodiment 2

[0106]

[0107] Preparation method: make 100 torpedo-shaped suppositories according to the method in Example 1, each weighing about 4.7g.

Embodiment 3

[0109]

[0110]

[0111] Preparation:

[0112] 1) Preparation of drug-containing matrix:

[0113] a. get lanolin and semi-synthetic coconut oil ester and place heating and melting in a water bath to obtain a melt;

[0114] b. Take triethanolamine oleate, add 2-6 times the amount of water, add secnidazole under stirring, mix well, and prepare the mixture;

[0115] c. mixing the mixture with a part of the melt of step a to obtain a drug-containing matrix;

[0116] 2) Preparation of suppositories:

[0117] a. Inject a part of the molten material obtained in step 1-a into the plug mold, place it, and turn over the plug mold, so that the uncondensed melt in the middle flows out to form a cavity;

[0118] b. Insert 1 / 5-4 / 5 of the front end of the non-woven fabric into the cavity described in step 2-a to form a cavity containing the non-woven fabric;

[0119] c. Pour the drug-containing matrix obtained in step 1) into the cavity containing non-woven fabric described in step...

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Abstract

The present invention relates to a secnidazole vaginal expansion suppository and its preparation method and detection method; the expansion suppository comprises secnidazole, a matrix and an expansion carrier, and the drug-containing matrix of the expansion suppository contains triethanolamine oleate Can increase the dispersion uniformity of secnidazole in matrix, improve the bioavailability of suppository; Described thyme oil can improve the lubricity of suppository and the dissolution rate of active ingredient secnidazole, increase the human body's to secnidazole The absorption of azole, improve the bioavailability of suppository; Described dextran can improve the treatment of suppository vulvovaginal candidiasis, promote the healing of erosion, ulcer, improve the immunity of human body; Described dextran can also promote suppository forming, improving the stability of the suppository; the secnidazole vaginal expansion suppository is a hollow double-layer expansion suppository, and the drug-containing matrix is ​​wrapped in the matrix layer, so that the suppository of the present invention is more stable than ordinary suppositories; and the The secnidazole vaginal expansion suppository adopts six original leading technologies, which have beneficial effects such as preventing the outflow of medicinal liquid, high stability, and remarkable curative effect.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a secnidazole vaginal expansive suppository and a preparation method and detection method thereof. Background technique [0002] Secnidazole is mainly used in the treatment of trichomonas vaginitis. Trichomonal vaginitis is caused by Trichomonas, which parasitize the human body, including Trichomonas vaginalis, Trichomonas hominis and Oral Trichomonas, which parasitize the genitourinary system, intestinal tract and oral cavity respectively, and are related to skin diseases The most common is Trichomonas vaginalis, which causes Trichomonas vaginitis. It is a parasitic disease that is mainly transmitted through sexual intercourse and is contagious. The preparations related to secnidazole in the prior art include tablets, injections and suppositories. The tablets and injections generally have the disadvantages of inconvenient use, low dissolution rate of secnidazole, difficult...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K31/4164A61K47/46A61K47/36G01N33/15G01N5/04A61P15/02A61P33/02
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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