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Sertaconazole nitrate vaginal expansive suppository as well as preparation method and detection method thereof

A technology of sertaconazole nitrate and vaginal expansive suppositories, applied in suppository delivery, pharmaceutical formulations, material inspection products, etc., can solve the problems of easily contaminated clothes, poor stability of suppositories, and slow drug onset, so as to avoid secondary infection , the effect of preventing outflow

Active Publication Date: 2014-07-02
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

But above-mentioned suppository also has poor stability, uneven drug release, slow drug onset and other technical problems; in addition, sertaconazole nitrate suppository also exists not easy to clean, easy to pollute clothes; active ingredient and human body contact surface is small, causes absorption insufficient, no Technical issues such as exerting the best curative effect of the prescription

Method used

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  • Sertaconazole nitrate vaginal expansive suppository as well as preparation method and detection method thereof
  • Sertaconazole nitrate vaginal expansive suppository as well as preparation method and detection method thereof
  • Sertaconazole nitrate vaginal expansive suppository as well as preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0081]

[0082] Preparation:

[0083] 1) Preparation of drug-containing matrix:

[0084] a. Polyethylene glycol 400 and polyethylene glycol 4000 are placed in a water bath and heated to melt to obtain a melt;

[0085] b. Sertaconazole nitrate is added to the melt in step a, and mixed uniformly to obtain a drug-containing matrix;

[0086] 2) Preparation of expansive suppository: Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 bullet-shaped suppositories, each weighing about 1.7g.

Embodiment 2

[0088]

[0089] Preparation:

[0090] 1) Preparation of drug-containing matrix:

[0091] a. Put poloxamer and glycerine gelatin in a water bath to heat and melt, add rosin glyceride under stirring, and mix well to obtain a melt;

[0092] b. Sertaconazole nitrate is added to the melt in step a, and mixed uniformly to obtain a drug-containing matrix;

[0093] 2) Preparation of expansive suppository: Pour the drug-containing matrix into the suppository mold, insert a tampon, cool and shape, and make 100 spherical suppositories, each weighing about 5.0g.

Embodiment 3

[0095]

[0096] Preparation method: make 100 cylindrical suppositories according to the method in Example 2, each weighing about 2.9g.

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Abstract

The invention relates to a sertaconazole nitrate vaginal expansive suppository as well as a preparation method and a detection method thereof. The expansive suppository contains a medicated matrix formed by sertaconazole nitrate and a matrix, and an expansive carrier, wherein the medicated matrix further contains glycerol ester of rosin therein, to relieve irritation of the expansive suppository on vagina; meanwhile, the sertaconazole nitrate is prepared into a micro-capsule with cross-esterified castor oil polyglyceryl ester, pullulan and chitosan, thus enhancing the stability of the expansive suppository; in addition, the expansive suppository has the characteristics of rapid speed of taking effect and durable pharmaceutical effect; sorbitan tristearate, sodium pyrosulfite and sodium starch phosphate are sequentially added in the medicated matrix, so that the prepared expansive suppository is uniformly dispersed in medicines, stable in nature, difficult to deform, less in possibility of rancidification and difficult to melt; in addition, by virtue of adopting seven unique leading technologies, the sertaconazole nitrate vaginal expansive suppository disclosed by the invention has the beneficial effects of preventing outflow of medicine liquid, avoiding secondary infection and the like.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a sertaconazole nitrate vaginal expansive suppository, a preparation method and a detection method thereof. Background technique [0002] Sertaconazole nitrate, chemical name 1-(2-((7-chlorobenzo(b)thiophen-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl) -1H-imidazole nitrate; it is a white crystalline powder, odorless; easily soluble in ethanol or chloroform, slightly soluble in acetone, almost insoluble in water, melting point 158-160°C; structural formula is as follows: [0003] [0004] Existing sertaconazole nitrate external preparation comprises ointment and suppository, because suppository has characteristics such as administration convenience compared with ointment, hygiene, suppository has been widely used; Clinically sertaconazole nitrate suppository is used for the treatment of mold Vaginitis and vulvovaginal candidiasis. [0005] For example, CN101375835 discloses...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/4174A61K47/36A61K47/34G01N33/15G01N5/04A61P15/02A61P31/10
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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