Studies On Preparation Technology And Quality Standard Of Yinlishuang Lotion

The Chinese herbal preparation Yinlishuang lotion, which is prepared by The Guangdong Provincial Corps Hospital Chinese People's Armed Police Forces, is consist of Phellodendron chinense cortex, Sophora flavescens radix, Cnidii fructus, Zanthoxyli pericarpium, Carpesii fructus, Stemonae radix, Kochiae fructus, Meliae cortex, Dictamni cortex, Borneolum syntheticum. It has the effect of clear away heat, dry dampness and wind-dispelling and itching-arresting. Yinlishuang lotion is used for negative itching,red swelling,causalgia, which causes by the vaginitis of mycotic and bacterium in the department of gynecology.Since the limitations of study and the standard of Chinese Pharmacopoeia 2000 about Yinlishuang lotion, and it discovers that the Yinlishuang lotion need have had an improvement in the preparation technology and quality standard since several years of clinical application. To solve these problems, orthogonal experiment design L9 (34) is used to optimize preparation technology by the using of modem medicine extraction and separation technology. At the same time, we add the strong specificity identifications and the content of determination, so that we can enhance the level of quality control,and control the quality of Yinlishuang lotion.Altogether, the research is on the foundation of optimizing the best preparation technology of Yinlishuang Lotion, also to carry on a research of establishing the quality standard for Yinlishuang lotion. The contents, method and conclusion of this research include a few of the aspects as follows:The first part of this paper is the literature research of the related disease vaginitis, which Yinlishuang lotion cures. The vaginitis is a familiar clinical gynecology diseases, leucorrhea to increase is the most familiar symptom of the vaginitis on clinic. The appearance of vaginitis is irruptive infection, which is caused by bacterium or arasite or dysbacteriosis in vagina in western medicine. Currently, more adopt the therapy of systemic anti-inflammatory and local anti-inflammatory. The traditional chinese medicine learns to think vaginitis,which induced by the dysfunction of liver and spleen and stomach funtcionbelong to "leukorrhea" and"pruritus vulvae" category. The traditional chinese medicine learns to put great emphasis on whole regulate for the therapeutics of vaginitis. regardless improving symptom and monopathy pathology, still keeps dispeling in addition to the cause of disease cures from the theory of the traditional chinese medicine,so it has its special place. The therapeutic effects of Yinlishuang lotion has something to do with the anti-inflammatory effect of Chinese herbal medicine closely, so the past overview Chinese herbal medicine influences the mechanism research of the disease vaginitis immunity reaction progress, Chinese herbal medicine,which influences on the research progress of the inflammatory immunological reactions'mechanism,is summarized, and the composing prescriptions and prescription drugs of Yinlishuang lotion is carring on studying analysis.The second part of this dissertation concentrated on the study on the quality standard of Yinlishuang lotion. By orthogonal experiment design L9(34),with extractive yield of volatile oil as an index, the optimal oil extraction condition was studied. Three factors were selected including water consumption, soaking time and extracting time. By orthogonal experiment design L9(34), with the content of berberine hydrochloride determined by HPLC as a quanlitative index, the optimal water extracting alcohol precipitating was studied. Four factors were selected including water consumption, extracting times, extracting time and the concentration of alcohol-sediment. The results have showed that the oil extraction condition is adding 10 times water, soaking for 1.5 hours and extracting for 6 hours. And the best water-extraction condition:boiled twice with 10 times water,2 hours for each time and 70% alcohol-sediment.The last part of this dissertation concentrated on the study on the quality standard of Yinlishuang lotion. Berberine hydrochloride was used as reference substance and trichloromethane-methanol-concentrated ammonia solution(50:10:1) as developer to identify Phellodendron chinense by TLC;Matrine as reference substance and methylbenzene-acetone- methanol(8:3:1) as developer to identify Radix sophorae flavescentis by TLC; Osthole as reference substance and methylbenzene-ethyl acetate- n-hexane (3:3:2) as developer to identify Fructus cnidii by TLC; HPLC was used to determine Berberine hydrochloride in phellodendron chinense,the column was ODS-C18 colunm, the mobile phase was Methyl Cyanides-0.1%phosphoric acid (50:50) (add sodium dodecyl sulfate 0.1g per 100 ml),the detection wavelength was 265mn. The results showed that, Yinlishuang Lotion and the control medicinal material of Phellodendron chinense,Radix sophorae flavescentis and Fructus cnidii with respectively check against an article and check against the position department that the reference substance, respectively same spot by TLC-identification, and the negative control solution have noninterference. The regression equation is Y= 4342774X+7252, r=1.0000 for berberine hydrochloride, and the linear range was (0.0908-2.2700)μg, the average recovery was99.8%,SD and RSD are 1.2%(n=6).