Studies On The Preparation Technology And Quality Standard Of Fuyanping Lotion

It is estimated by World Health Organization (WHO) that new female genital tract infections were as high as333million each year. The epidemiological investigation in50cities (districts) from15provinces or municipalities shows that in urban married females the incidence of genital tract infection reachs up to42.9%. Fuyanping is a kind of traditional Chinese herbal preparation developed on the base of a clinically proved recipe, which contains nine kinds of medicinal materials such as Sophora flavescens, boric acid, dried alum, Picrasma quassioides, pearl toffee, etc, which shows heat clearing, detoxifying, dampness eliminating, and antipruritus effects and are used in the treatment of vaginitis or vulvitis caused by trichomoniasis, mold, and bacteria. At present thare are only Fuyanping capsules, powder, and effervescent tablets available in the market. In order to provide more convenient dosage forms for the clinic, we study the preparation technology and quality control of Fuyanping lotion.In this paper, we studied the preparation technology of Fuyanping lotion adopting the parallel test method to optimize and to determine the optimum process parameters. Its technology was as follows:Borneol and menthol were dissolved in appropriate mount of ethanol. Ten grams of the Cnidium monnieri seeds were crushed into the fine powder, and the rest was percolated with six times of ethanol (85%). Sophora flavescens was percolated with six times of ethanol (50%), while Picrasma quassioides was refluxed in ethanol (85%) two times, each for two hours. The above ethanolic extracts were all concentrated under reduced pressure and then mixed together with the solution of borneol and menthol, pearl toffee, berberine hydrochloride, boric acid, dried alum, and fine powder of Cnidium monnieri. Appropriate amount of supplementary material was then added and grinded, followed by adding of water to a total volume of1000mLThe quality control of the product was also studied and an improved new quality standard was established. In the studies, berberine hydrochloride, quassia, osthole, matrine, borneol, and menthol were identified by thin layer chromatography (TLC) and content of berberine hydrochloride was determined by high performance liquid chromatography (HPLC). The HPLC was performed on a C18column with phosphate buffer [0.05mol/L of monopotassium phosphate and0.05mol/L of sodium heptanesulfonate (1:1), containing0.2%triethylamine, and pH adjusted to3.0with phosphoric acid]-acetonitrile (60:40) as mobile phase. Berberine hydrochloride had good linear relationship from20.32μg/mL to81.28μg/mL, the average sample recovery rate was98.36%, and RSD was1.87%. Three batches of samples were analyzed and the content of berberine hydrochloride was within the rules. In addition, the long-term stability test (9months) and accelerated stability test (6months) of the three batches of samples were also conducted. The preparation technology of Fuyangping lotion was reasonable and feasible and the quality standard could be used in the quality control of the product, which provided basis for new drug development for department of gynaecology.