祛疣软膏的药学部分研究

【作者】 李玲；

【导师】 付超美；

【作者基本信息】 成都中医药大学 ， 药剂学， 2003， 硕士

【摘要】 祛疣软膏是由黄连、紫草、败酱草、虎杖、白矾、天花粉等中药制成的复方制剂，具有清热解毒、燥湿祛疣的功效。用于治疗湿热下注，复感淫秽、湿热邪毒结聚生殖器、会阴部、肛门而发尖锐湿疣。本课题以传统中医药理论为指导，运用现代制药技术，对该软膏剂进行了临床前药学部分的研究工作，考虑临床用药的需要，结合处方用药的性质，确定剂型为软膏剂。根据处方的功能主治及药物所含成分的理化性质，采用正交实验方法以多指标综合评分筛选最佳工艺为：取黄连、败酱草、紫草三味药材粉碎成粗粉，照渗漉法(《中国药典》2000年版一部附录ⅠD)用70％的乙醇10倍量作溶剂，浸渍24小时，以每分钟3ml的速度缓缓渗漉，收集渗漉液，静置，滤过，滤液减压回收乙醇，并浓缩至相对密度为1.20(60℃)的清膏，备用；其余虎杖、天花粉加水煎煮3次，每次1小时，第一次加10倍量水，第二次加8倍量水，第三次加6倍量水。合并煎液，滤过，滤液浓缩至相对密度为1.10(60℃)的清膏，加入乙醇使含醇量50％，静置12小时，滤过，滤液回收乙醇，备用；称取油相基质，与上述醇提清膏合并；另取水相基质，加入白矾，与上述水提药液合并；将油相、水相加热至80℃，以乳化法制得软膏，冷却至40℃，加入冰片，搅匀，即得。对该制剂进行了质量标准，确定了以HPLC法测定该方君药黄连所含盐酸小檗碱的含量，并建立了相应的测定方法和含量限度，同时对方中虎杖、天花粉、冰片进行了薄层色谱鉴别。在质量标准可控的基础上对该制剂进行了初步稳定性研究。以上试验结果表明：制备工艺合理可行，质量标准可控，成品质量基本稳定。更多还原

【Abstract】 Quyou ointment is a new compound preparation of Traditional Chinese Medicine, which consists of Rhizoma Coptidis, Radix Lithospermi, Rhixoma Polygoni Cuspidati, Borneolum Syntheticum and three other herbs. It has the function of clearing away Heat-toxin, eliminating Dampness and removing wart. It can be used to cure wart which caused by Dampness and Heat invading downward, filthy and turbid invasion, Dampness-Heat and toxin blocks in the reproduction zone, perineum, anus.With the guidance of the theories of Traditional Chinese Medicine, Quyou ointment was studied with modern pharmaceutical technology. For the demand of clinic, the form of drug was chosen as ointment. On the basis of the function and treatment as well as the characters of the component of the herbs, the optimum extract conditions were selected by using orthogonal design. Pulverize Rhizoma Coptidis, Radix Arnebiae and Patrinia scabiosaefolia Fisch to coarse powder, carry out the method for percolation, using 70% ethanol as solvent to macerate for 24 hours and then to take percolation. Collect the percolate, then recover ethanol and concentrate to a concentrated solution with a relative density of 1.20(60℃) for latter use. Decoct Rhizoma Polygoni Cuspidari and Radix Trichosanthis with water 8 times, 1 hour for each time, combine the decoctions and filter. Combine the filter and concentrate the filtrate until its relative density is about 1.10(60℃). Allow cool to the room temperature, add ethanol to produce a solution containing 50% of ethanol, stir well, standing 12 hours, filter, recover ethanol for latter use. Add above percolations to oil substrate and add above decoctions to water substrate. Combine Alumen with water base substrate and add water to 1000ml include water phase and oil phase. Raise the temperature to 80 ℃ and use agent-in-oil method to form the ointment. Add Borneolum Syntheticum to ointment when cool to 40 ℃, stir well. After that the quality standard of the Quyou ointment was finished. Determine the content ofRhizoma Coptics in Quyou ointment by RP-HPLC. Use TLC to identify Rhizoma Polygoni Cuspidati, Radix Trichosanthis and Borneolum Syntheticum. Then the preliminary stability was fulfilled. That research indicates that the technique of preparation was reasonable and practical, the standard was controllable and the quality of the sample were steady as well.更多还原