【作者】 唐坤；

【导师】 王伯初； 蔡应繁；

【作者基本信息】 重庆大学 ， 生物医学工程， 2006， 硕士

【摘要】 复方蜂胶乳膏由蜂胶、苦参、黄芩、防风四味中药组成,具有清热解毒,消肿止痛,凉血化瘀的功效,主要用于治疗带状疱疹、湿疹等皮肤疾病。通过对复方蜂胶乳膏的药学研究,为带状疱疹患者提供一种安全、有效、便捷的中药外用新制剂。药材的提取研究分为两部分:蜂胶的提取采用了微波和超声波法,以总黄酮的含量为检测指标,通过正交试验设计确定了最佳提取工艺条件,结果为15倍量80%乙醇,在微波功率600W下处理5min,置于70℃温水浴中超声提取2次,每次提取20min。其余药材的提取采用水提醇沉工艺,即通过正交试验,以苦参碱和浸出物为检测指标,应用HPLC法考察了4种因素（加水量、煎煮时间、煎煮次数、醇沉浓度）对其含量的影响.结果最佳提取工艺条件为加8倍量水,煎煮2次,每次煎煮1hr,醇沉至60%。制剂研究主要利用均匀设计法筛选适宜基质制成o/w型的乳膏。即采用乳化法,以乳膏外观、粒度分布和以所制乳剂离心分层后油层的高度为考察指标来优化处方。结果以油相体积分数占27%、乳化剂用量为5%、HLB值为11、乳化温度为80℃为最佳条件。按此条件制备的乳膏色泽均匀、质地细腻。质量标准建立了黄芩、蜂胶的薄层色谱鉴别;制定了乳膏的PH值范围;采用高效液相色谱法建立了苦参碱的含量测定,以及应用紫外分光光度法建立了乳膏中总黄酮的含量测定。结果薄层鉴别的方法简单可行;乳膏pH值为5.0～7.0;苦参碱在40.00～200.00 mg.L^-1呈现良好的线性关系（r=0.9998）,平均回收率为98.44%,RSD为1.97%（n=6）,含量限度为每克乳膏不少于0.7mg;芦丁检测浓度线性范围7.92μg/ml～47.52μg/ml （ r =0.9997）,平均回收率为98.35 %,乳膏中的总黄酮不应少于0.20mg/g。该质量控制的方法简单、专属性强、重现性好,可较好控制产品质量。三批样品的初步稳定性实验表明,药品在常温、高温（40℃）、低温（4℃）下连续放置3个月,各项考察项目均符合规定,结果表明本品基本稳定。对乳膏进行了部分动物实验研究,包括皮肤急性毒性试验、单次给药和多次给药的皮肤刺激性试验,以了解其安全性。结果乳膏未产生急性毒性和皮肤刺激性,表明复方蜂胶乳膏是较安全的新型外用制剂。更多还原

【Abstract】 The compound propolis cream is comprised of propolis、Radix sophorae flavescentis、Radix scutellariae、Radix saposhnikoviae.It is applied mainly to treat herpes zoster and eczema. To pharmic research and develop a new preparation of the Compound propolis, which is effective on herpes zoster’sufferer. To discuss the rationality of the Compound propolis contains traditional Chinese medicine through the safety and efficiency of the new preparation.The extraction of Chinese traditional medicine has divided into two parts: extraction of propolis is used microwave and ultrasonic treatment, with the content of total flavonoids as the evaluating index , then selected the optimal extraction condition of propolis by orthogoral test. The results as follows: 80% alcohol as solvent and dose of 15-fold medicinal materials, the power of microwave 600W, the treatment time of microwave 5minutes, and the ultrasonic extracing two times, 20min in each time at 70℃in water.The extraction technology of other traditional Chinese medicine was water extracting and alcohol precipitation, namely using orthogonal test, with matrine and the whole solids as index, to study the effect of four extracting factors （the amount of water, the extracting time and times and the concentration of alcohol precipitation） by HPLC.The result of optimal extracting conditions was added 8 fold of water, extraced two times for 1hr in each time, the 60% concentration of alcohol precipitation. As a result, the process is reasonable and favorable for extration process.The preparation reasearch was mainly selected appropriate base to prepar the o/w type creams by uniform design. Namely the optimization of preparation process by emulsion solvent method, using morphological characteristics of creams, partical size distribution and the height of oil layer in the centrifuged emulsion as evaluating criterion. The optimum matrix composition and technology were the oil phase of volume faction is 27%, emulsifying agent 5%, HLB 11 and emulsifying temperature 80℃, then the emulsion prepared by this kind of composition and technology was homogeneous, exquisite.The quality standard for compound propolis cream was established the identification of Radix scutellariae and propolis by TLC, set down the range of pH, and erected the contend of matrine by HLPC and total flavonoids by spectrophotometry. The result was that the methods of identification was simple and feasible; the range of pH was 5.0～7.0; and the calibration curves of matrine were linear between 40.00-200.00 mg.L^-1 （r=0.9998）, the average recoveries of matrine in compound propolis creams were 98.44%, RSD were 1.97%（n=6）, the limits of matrine’contents in creams was no less than 0.7mg/g; and the linear range of rudin was 7.92μg/ml-47.52μg/ml （r =0.9 997）, the更多还原