Vaginal effervescent tablet with biological adhesiveness and preparation process thereof

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...

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, and tends to aggregate into large lumps, which reduces the effect of micronization of raw materials, which in turn affects the curative effect of this product, and After terbinafine drug residue leaked onto clothing, it was difficult to wash off

In addition, the granulation process adopted by the existing terbinafine vaginal effervescent tablets uses anhydrous ethanol as a wetting agent, which is not conducive to environmental protection requirements, and has high requirements for explosion-proof workshops, and there is a certain risk

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