Vaginal effervescent tablet with biological adhesiveness and preparation process thereof

A bioadhesive and bioadhesion technology, applied in diseases, medical formulas, drug combinations, etc., can solve the problems of easy residue of substances, reduced effect, difficult to clean, etc., to improve curative effect, improve compliance, improve The effect of solubility

Inactive Publication Date: 2012-09-19
JINAN KANGHE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the vaginal effervescent agent of terbinafine hydrochloride has been sold on the market, but after the patients use it, they find that there are many inconvenient factors. For example, due to the large amount of water-insoluble excipients used in the prescription, these substances are easy to remain after the patients take the medicine. Difficult to discharge in vaginal wall folds
In addition, in our experimental research, we unexpectedly found that terbinafine hydrochloride becomes sticky when exposed to water, a

Method used

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  • Vaginal effervescent tablet with biological adhesiveness and preparation process thereof
  • Vaginal effervescent tablet with biological adhesiveness and preparation process thereof
  • Vaginal effervescent tablet with biological adhesiveness and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021]

[0022] Preparation method:

[0023] (1) Get the raw materials of each weight and dry them respectively to less than 1.0% of the moisture content, and pulverize them through a 100-mesh sieve for subsequent use;

[0024] (2) After fully mixing the prepared terbinafine hydrochloride and Tween 80, add the prepared effervescent agent, bioadhesive agent, filler, and fully mix, adopt dry granulation process to granulate;

[0025] (3) Fully mix the granules with the prepared lubricant, take a sample to detect the content of the intermediate, and determine the tablet weight;

[0026] (4) The qualified granules are compressed into tablets by special-shaped dies to obtain 1000 tablets;

[0027] (5) Pack qualified tablets in double aluminum-plastic packaging.

Embodiment 2

[0029]

[0030]

[0031] Preparation method: with embodiment 1.

Embodiment 3

[0033]

[0034] Preparation method: with embodiment 1.

[0035] Investigation on the accelerated test of bioadhesive vaginal effervescent tablet of the present invention

[0036] The effervescent tablets prepared by the above 3 examples are carried out in an accelerated test to evaluate the quality of the prepared samples of the present invention.

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PUM

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Abstract

The invention discloses a vaginal effervescent tablet with biological adhesiveness and a preparation process thereof. The vaginal effervescent tablet with biological adhesiveness is characterized by comprising active pharmaceutical ingredients including terbinafine hydrochloride, an effervescent agent, tween-80, a biological adhesive, a filler and an emollient. The effervescent agent includes an acid-source component and an alkali-source component. The biological adhesive is composed one or multiple of chitosan, Carbomer, sodium carboxy methyl cellulose and hydroxypropyl methylcellulose. The effervescent tablet prepared by the preparation process can be distributed in the human body uniformly and easy to clean and has biological adhesiveness so as to adhere onto the vaginal wall for a long time and prevent from flowing out of the vagina within a short time, and accordingly therapeutic effect is improved further.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a bioadhesive vaginal effervescent tablet and a preparation method thereof. Background technique [0002] Gynecological infection is a common and frequently-occurring disease. Candida vaginitis is a common mucosal Candida infection. Most women have a history of infection with this bacteria, and many patients have a history of repeated infection. Studies have shown that oral contraceptives, diabetes, immunodeficiency, long-term use of antibiotics, environmental factors, and nutritional status are all related to the occurrence of this disease. 80% to 90% of candidal vaginitis is caused by Candida albicans. In recent years, with changes in people's lifestyles and eating habits, work pressure, antibiotic abuse and other reasons, the incidence of candidal vaginitis is gradually increasing. Clinically commonly used therapeutic drugs include nystatin cream, supposi...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K31/137A61K47/38A61K47/36A61P31/04A61P15/02
Inventor 张颖李刚杨延坤秦政
Owner JINAN KANGHE MEDICAL TECH
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