Matrine vaginal effervescent tablets with bilayer structure and preparation method

Abstract

The invention discloses a matrine-containing vaginal effervescent preparation. The preparation comprises an alkaline inner layer and an acidic outer layer, is used for treating vaginal infection of women and gynecological inflammation caused thereby, has a reasonable formula and cannot cause adverse reactions such as vulvovaginal stimulation symptoms and the like. In addition, the invention also relates to a preparation method and application of the preparation in preparation of medicaments for treating diseases such as bacterial vaginosis, candidal vulvovaginitis and / or trichomonas vaginitis and the like.

Description

technical field The invention belongs to the field of pharmaceutical preparations of traditional Chinese medicine extracts. Specifically, the invention relates to vaginal effervescent preparations containing matrine, which has an alkaline inner layer and an acidic outer layer, and is used for treating women's vaginal infections and thus Brought gynecological inflammation. In addition, the present invention also relates to the preparation method and application of the preparation. Background technique Gynecological diseases, such as trichomonal vaginitis, monilial vaginitis, chronic cervicitis, senile vaginitis, pelvic inflammatory disease, etc., are common gynecological diseases, which have the characteristics of recurrent attacks and lingering and difficult to heal. The disease is often caused by trichomonas, mold and bacterial infections, and can also be caused by mixed infections. The treatment of this disease is mainly based on topical vaginal application of antibiotic...

AI Technical Summary

Problems solved by technology

However, we found that such preparations are either directly neutralized by acid and base, causing the preparation to be very unstable, or the base of the outer layer is neutralized by the acidic environment of the vagina, and it cannot prevent the ingredients in the inner layer of particles from diffusing to the outer layer and Neutralization, not only the preparation is unstable, but also the efficiency of releasing the active ingredient is very low, and the alkali in the outer layer may even bring a certain stimulating effect to the human body. These restrictive factors have led to the fact that this technology has not been practically applied and promoted so far.

Chinese patent application 200410013177.1 involves the compound preparation of matrine and borneol. The increase of active ingredients will bring geometric progression to the difficulty of production quality management, which greatly increases the production cost, and the patent does not specifically involve the innovation of the preparation

However, we found that on the one hand, such preparations have complex adjuvant components and require a precision of 30 mesh sieves, which greatly increases the production cost and the difficulty of production quality management; more importantly, because the human vagina is not a pure fluid environment, part of it The disintegrated alkaline granules will not touch the acidic granules but directly contact with the vagina, and even cause local alkalinity, while the acidic granules will even persist in the vaginal environment for a long time due to the presence of the adhesive, which will cause adverse effects on the vagina. Irritation to the human body, and because the acid in the tablet itself is not fully utilized, the release efficiency and uniformity are reduced, sometimes it is impossible to form a continuous foam, and it is even difficult to achieve the curative effect of the existing matrine suppository. Restricting factors lead to the fact that the technology has not been practically applied and promoted so far

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