| ObjectivesShenhuang lotion is based on the theory of traditional Chinese medicine applied to clinical experience for many years.The purpose of this study was to further develop the prevention and treatment of vaginitis by using Shenhuang lotion,and to extract the active ingredients such as sophora flavescens and cortex phellodendron chinensis.The quality standard and preliminary stability were studied to provide scientific basis for the further development of shenhuang lotion.Methods1 Orthogonal experiments were carried out on four single factors,including extraction times,soaking temperature,soaking time and ratio of material to liquid.The content of matrine,berberine hydrochloride and dry paste yield of two index components were used as the test indexes,and the best extraction process of shenhuang lotion was selected by comprehensive scoring.In the alcohol precipitation process,the concentration,temperature and precipitation time of the concentrated solution were investigated,and the best preparation conditions were obtained.2 Matrine,Berberine and Rheophenol in shenhuang slotion were identified by thin layer chromatography.3 According to the addenda general rule of the lotion in the 2015 partⅣof Chinese Pharmacopoeia,a series of quality studies about shenhuang lotion performed as:pH value,flask content,microbial limit.4 The content of matrine and berberine in shenhuang lotion was evaluated by High performance liquid chromatography to determine the quality standard of the preparation.5 The preliminary stability of the shenhuang lotion was investigated with reference to（Appendix II of the 2005 edition of the Chinese Pharmacopoeia）.Three batches of samples were tested for long-term stability for 9 months and accelerated test for 6 months to check the character,identification,pH value,microbial limit and content.Results1 Orthogonal test screening process conditions for the extraction of two times,soaking temperature 40℃,the immersion time two hours,material liquid than 1:10(g·mL-1),decoction two and merge decoction,filtration,will be two times after extraction of the extract concentration to 1000 mL,sank alcohol concentration 60%,alcohol sink under room temperature,the time for 24 hours.2 The results of the stereotyped identification of shenhuang lotion:spot color clearly,negative without interference.3 pH microbial limit,flask content were up to the general rule of lotion in Chinese Pharmacopoeia 2015 edition.4 The content determination method of HPLC was established,and two index components were experimentally verified in the column:EclipseXOB-C18（5μm,4.6×150mm）,columntemperature:30°C;Mobile phase:acetonitrile-1 phosphoric acid solution（pH6.8,80:20）;The detection wavelength is 220nm;Flow rate:0.8 mL/min,The method has good separation and reliability.5 Preliminary stability test of three batches of samples under simulated listed packaging,respectively in the temperature of 40℃+2℃,relative humidity of 75%plus or minus 5%next placed in June,the temperature is 25℃,relative humidity under the condition of 60%plus or minus 10%in September,the test results compared with 0 month,its appearance,pH value,there were no obvious changes in contents of samples,show that preparation stability testing qualified.ConclusionsThis experiment has completed the extraction and preparation of shenhuang lotion preparation process,the process is relatively simple without special equipment,the production cost is low and the quality is stable,the preparation process of environmental pollution is small,for shenhuang lotion in clinical further development and research and preparation of standardized production pave.In addition,this experiment to improve the quality standards,to establish the qualitative identification of TLC and HPLC,to determine the content of the composition index determination method,the method is simple,stable and reliable,and provide scientific basis for further research,but due to time and resource problems,not pharmacokinetic experiment and clinical test,this study can be used as the basis.Figure28;Table21;Reference 83... |
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