Study On Metronidazole Compound Gel

Metronidazole Compound Gel made up of Metronidazole and Lactic acid bacteria. The pathogenesis of bacterial vaginosis(BV for short) was expounded; the rationality and necessity of making Metronidazole Compound Gel as well as its perspective of clinical use were analyzed in this paper. Modern pharmaceutical technique was used for formulation screening, quality study and stability investigation. The paper consists of three parts.The first part is an overview of literatures which expounds on BV's definition, characteristics and pathogenesis. BV is Endogenous microbial infection which leads by the increase of Gardner's bacteria and Lactobacillus reduces. The clinical performance is the increase of vaginal discharge. It is gray uniform lean secretions which with Anabaena smell or vaginal itching. In severe cases, it would lead to infertility. The increase of Gardner's bacteria is the important factor of BV. Metronidazole has important fact of anti-anaerobic, while Lactic acid bacteria have significance of resumption of the vaginal flora balance. Thus Metronidazole and Lactic acid bacteria are made into a compound gel, which may presents a very good therapeutically effect of treating BV and possesses a good perspective in clinical use.The second part expounds the design,screening of prescription, and the research of preparation. The design of prescription includes the choice of accessory and single factor inspection. Reference to the relevant literature, the compound formulation was effective when the proportion ratio was of 1% Metronidazole and 1.5% Lactobicillin. The product obtained was a Light yellow transparent gel, with a pH between 6.0 and 7.0. As the screening of prescription, we inspected on the temperature of the preparation and the order of joining the main drug, we investigated the effect of the quality with different preparation.The third part is quality study, specification establishment and stability study etc. This part inspected the quality of the preparations and developed a standard of it. The stability of this product was studied by influential factor test, accelerated test and long term test and there results showed that this product was relatively stable to illumination, high temperature and high humidity. None of the parameters significantly changed during the 6 month accelerated test and long term test (l~ 9month) which showed that this product was stable at common temperature. 9~ 36 month stability is still under investigation.