| Pruritus vulvae with a high attack rate is most common Gynecological disease. There are many medicine to treat this disease internal at present,most of which are chinese traditional medicine.Western medicine is only single preparation,which do not have the function of curing itch,dephlogistication and bacteriostasis simultaneously.On the basis of the requirement,lidocaine,benadryl hydrochloride, EX and thymol are taken as the model drugs to prepare the compound ointment which has rapid curative effect.After the investigation of emulsifier and basis material,we selected and optimized the formula by orthogonal design.The compound ointment was composed of peregal, liquid paraffin, docosyl alcohol, glyceryl monostearate, glycerin, isopropyl myristate and water.The study also includes praeparatum technology of the formula.An HPLC method was established to determine three constituent content in the same chromatographic condition. The drugs were eluted with the mobile phase of methanol-buffer phosphate(pH8.0)-acetonitrile(60:25:15) at the flow rate of 1.0mL·min-1 on a C18 column at 35℃. The drugs were detected at the wavelength of 255nm. After validating,the method is convenient,rapid,accurate and reliable.We also established HPLC methods to determine the content of vitamin E and related substances of lidocaine and benadryl hydrochloride respectively.The physicochemical properties and stability of compound ointment were studied.The appearance,pH value, fusing point and consistance of the ointment all conformed to the pharmacopoeia stipulation. The ointment style was qualified by staining method as oil-in-water .From influential factors experiments, accelerated tests and room temperature trials, it could be concluded that EX and thymol were unstable,so the ointment should be preserved away from light in room temperature.
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