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Nystatin expandable vaginal suppository, and preparation method and detection method thereof

A vaginal expansion suppository and nystatin technology, which is applied in the directions of suppository delivery, measuring device, pharmaceutical formulation, etc., can solve the problems of easily contaminated clothes, difficult to clean, and little research on nystatin suppositories, etc., to avoid secondary infection, The effect of preventing outflow

Active Publication Date: 2014-01-22
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

[0003] Nystatin suppositories are included in the fifth volume of "National Standards for Local Standards of Chemical Drugs", which are mainly used for vulvovaginal candidiasis; CN101254201 also discloses a semi-synthetic combination with nystatin and menthol as active ingredients. Suppositories made of fatty acid glycerides; there are not many studies on nystatin suppositories in the prior art, and because nystatin itself is unstable in nature, after being made into suppositories, the stability is poor; and common nystatin suppositories also have the difficulty of Clean and easy to contaminate clothes; the active ingredient has a small contact surface with the human body, resulting in insufficient absorption and failure to exert the best curative effect of the formula and other technical problems

Method used

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  • Nystatin expandable vaginal suppository, and preparation method and detection method thereof
  • Nystatin expandable vaginal suppository, and preparation method and detection method thereof
  • Nystatin expandable vaginal suppository, and preparation method and detection method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095]

[0096] Preparation:

[0097] 1) Preparation of drug-containing matrix:

[0098] a. heating and melting hypromellose and fractionated palm oil in a water bath to obtain a melt;

[0099] b. mixing nystatin with the melt of step a evenly to obtain a drug-containing matrix;

[0100] 2) Pour the drug-containing matrix into a suppository mold, insert a tampon, cool and shape, and make 100 conical suppositories, each weighing about 3.4g.

Embodiment 2

[0102]

[0103] Preparation:

[0104] 1) Preparation of drug-containing matrix:

[0105] a. Semi-synthetic palm oil ester and propylene glycol stearate are placed in a water bath for heating and melting to obtain a melt;

[0106] b. Take hydroxypropyl-β-cyclodextrin and add 3 times the amount of water, fully grind to a paste with a moisture content of less than 5%, add nystatin under grinding, mix well, and freeze-dry to obtain clathrate thing;

[0107] c. Mix the clathrate of step b and the melt of step a uniformly to prepare a drug-containing matrix;

[0108] 2) Pour the drug-containing matrix into the suppository mold, insert the tampon, cool and shape, and make 100 cylindrical suppositories, each weighing about 5.0g.

Embodiment 3

[0110]

[0111] Preparation method: make 100 rod-shaped suppositories according to the method in Example 2, each weighing about 1.9g.

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PUM

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Abstract

The invention relates to a nystatin expandable vaginal suppository, and a preparation method and a detection method thereof. The expandable vaginal suppository comprises a drug-containing matrix formed by nystatin and a matrix, and an expansion carrier. The nystatin and beta-cyclodextrin form a clathrate compound to improve the solubility and stability of the nystatin; calcium glycerophosphate in the drug-containing matrix can reduce hygroscopicity of the nystatin and increase the stability of the suppository; and the drug-containing matrix of the suppository further includes a special curing agent. The nystatin expandable vaginal suppository provided by the invention employs seven originally created leading technologies, and has the beneficial effects of prevention of outflow liquid, high stability, lasting effect and prevention of secondary infection.

Description

technical field [0001] The invention belongs to the field of vaginal suppositories, in particular to a nystatin vaginal expansion suppository and a preparation method and detection method thereof. Background technique [0002] Nystatin, a polyene antifungal antibiotic, is a yellow or brownish yellow powder with hygroscopicity, is unstable to light, air, acid and alkali, and is slightly soluble in water; it is mainly used clinically for vulvovaginal Candida sick. The dosage form development of nystatin has been very unsatisfactory, which has affected the application of nystatin. The current marketed preparations mainly include tablets and suppositories; after the tablet is inserted into the vagina, nystatin cannot dissolve and is difficult to play a role; so the current suppository The most widely used, accepted by the majority of patients. [0003] Nystatin suppositories are included in the fifth volume of "National Standards for Local Standards of Chemical Drugs", which a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/02A61K31/7048A61K47/48A61K47/24G01G17/00G01N33/15A61P15/02A61P31/10
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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