Tinidazole/miconazole nitrate/neomycin self-microemulsion soft capsules for vagina and preparation method thereof

Abstract

The invention belongs to the field of medicinal preparations, and relates to self-microemulsion soft capsules containing tinidazole/miconazole nitrate/neomycin for vagina and a preparation method thereof. The self-microemulsion soft capsules for the vagina consist of tinidazole, miconazole nitrate and neomycin sulfate in treatment effective dose, and can be used for multiple vaginitis. The methodfor preparing the self-microemulsion soft capsules comprises the following steps: heating surfactant, co-surfactant and oil phase to melt, adding the tinidazole, the miconazole nitrate and the neomycin sulfate in prescription amount into the melted mixture, and stirring the mixture till dissolving to obtain the self-microemulsion soft capsules. The self-microemulsion soft capsules prepared by themethod improve the bioavailability of the medicament in vivo, have quick response, and overcome the defect that the common vaginal tablets have lower bioavailability; and meanwhile, serving as a new composite dosage form, the formulation is scientific and novel and can provide a newer and better dosage form selection for both doctors and patients. The preparation process is simple and has no special requirement on preparation environment, the cost is low, the product quality is stable, and the preparation method is suitable for industrialized production.

Description

Technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a tinidazole / miconazole nitrate / neomycin self-microemulsion soft capsule and a preparation method thereof. Background technique [0002] Tinidazole has antiprotozoal and obligate anaerobic effects. It has inhibitory effects on protozoa such as Trichomonas vaginalis, Entamoeba histolytica and Giardia lamberii, and has an inhibitory effect on most anaerobic and Bacteroides fragilis , Bacteroides melanogaster, other Bacteroides, Clostridium, fungi, Fusobacterium, Haemophilus vaginalis, Peptococcus, Peptostreptococcus and Wechsococcus can inhibit or kill. It is suitable for bacterial vaginosis caused by trichomonal vaginitis and sensitive anaerobic bacteria. There are currently single suppositories used. [0003] Miconazole nitrate is a broad-spectrum antifungal drug, which has antibacterial effect against a variety of fungi, especially Candida, and also has antibacterial effect a...

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Problems solved by technology

[0005] At present, both tinidazole and miconazole nitrate have suppositories on the market, but neomycin sulfate has not been used in suppositories, and there are no related reports on the joint preparation of the three into self-microemulsifying capsule preparations for vaginal use

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