Clotrimazole vaginal tablets

Abstract

The invention discloses clotrimazole vaginal tablets and a production method thereof. Raw materials and process parameters are optimized comprehensively, and it is unexpectedly found that the clotrimazole vaginal tablets have a good slow release effect, are not required to be combined with oral medication and have a good control effect on recurrence of recurrent vulvovaginal candidiasis under the optimized parameters. The method comprises steps as follows: (1) material preparation in parts by weight: (2) pretreatment: all raw and auxiliary materials, except kushenin powder and nano tourmaline powder, are sieved by an 80-mesh sieve for later use; the kushenin powder is sieved by a 200-mesh powder for later use; the particle size of the nano tourmaline powder is selected to range between 8 nm and 12 nm; (3) granulation: the raw and auxiliary materials are weighed according to a prescription, placed in a high-speed mixing granulator for mixing and subjected to wet granulation with a lactic acid aqueous solution; (4) drying: prepared wet granules are dried at 60 DEG C for 4 h; (5) granulation and whole mixing: dried granules are placed in a 3D motion mixer to be uniformly mixed as a batch; (6) tableting: tableting can be performed after the granules pass inspection, and each table contains 500 mg of clotrimazole.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a clotrimazole vaginal tablet and a production process thereof. Background technique [0002] Clotrimazole is an imidazole broad-spectrum antifungal drug, used for candida vulvovaginitis and infectious leucorrhea caused by yeast, and has good antibacterial effect on various fungi, especially Candida albicans. Its mechanism of action is to inhibit the synthesis of fungal cell membrane and affect its metabolic process. Primarily through inhibition of ergosterol synthesis, inhibition of ergosterol synthesis results in impaired structure and function of the plasma membrane. Clotrimazole has antifungal activity both in vivo and in vitro, including dermatophytes, yeasts and molds. The chemical name of clotrimazole is bisphenyl-(2'-chlorophenyl)-1-imidazolylmethane, English / Latin name: Clotrinazole. This product is white or yellowish crystalline powder, odorless and tast...

AI Technical Summary

Problems solved by technology

However, this technology only solves the problem of sustained release of clotrimazole vaginal tablets, and has no special effect on controlling the recurrence of recurrent Candida vaginitis

[0005] The present invention aims to provide a new clotrimazole vaginal tablet and its production process. It is fully optimized from raw materials to process parameters. It is unexpectedly found that under the optimized parameters, it not only has a good sustained-release effect, but also does not need to be combined with oral administration. Medication is very effective in controlling the recurrence of recurrent Candida vaginitis, and such a process has not been reported