治疗湿疹的新药防茄软膏的研制

【作者】 杨安；

【导师】 苏明武；

【作者基本信息】 湖北中医学院 ， 中药学， 2004， 硕士

【摘要】 防茄软膏是一种不含激素的纯中药外用制剂，来源于疮疡等验方，根据中医药药理及实际经验进行了适当地加减组合而成，由虎杖、当归、防已、紫草、红花等中药经提取，再经软膏剂型调配而成的软膏制剂。处方中所有药物均收载于《中国药典》。软膏剂亦为常用剂型。本制剂组方独特，具有创新性。主要用于治疗湿疹，有独特的疗效，目前国内治疗该类疾病的药物虽然不少，如鹅掌风、华佗膏、皮康软膏、皮康王、救肤软膏、复方康纳乐软膏、健疗软膏、去炎松软膏、肤轻松软膏、皮炎平软膏、倍氯美松软膏、氧化搓锌软膏等等。据临床调查均有感其疗效欠佳，用后多有复发，不能完全治愈，从而可见目前国内外还没有治疗湿疹的特效药物。 随着本品的开发成功，将填补国内外目前尚无治疗湿疹特效药的空白。 湿疹的发病率较高，儿童为95％，成人约为12％，本品所用的原料无毒，价格便宜，成本低廉，市场前景广阔，预期的经济效益和社会效益可观。 本课题旨在研究防茄软膏的制备工艺及其质量控制标准。我们通过查阅大量的中医药文献和史料，依靠专家进行处方论证，选择软膏剂为剂型，并对其制备工艺、质量标准、药效学等方面进行了深入的研究，制定出了防茄软膏的组方及软膏的制备方法；制定出了防茄软膏在制剂过程中的质量控制标准；对其主要的药效学和毒理学进行了初步的探讨与考察，并进行了临床的初步试用，具体情况如下： 本课题对防茄软膏的制备工艺进行了研究，采用了正交试验设计来寻找制备工艺的最佳方案，大致可分为两步进行： (一)中药的提取： 1、以君药虎杖中特有成分白藜芦醇苷的含量为指标，设计防已、虎杖、赤芍、当归等药物的乙醇回流提取工艺，以乙醇浓度、回流时间、回流次数及乙醇的用量为考察因素，进行了4因素3水平的正交试验，得到了乙醇回流提取的最优工艺。 2、以君药白芷中的欧前胡素的含量为指标，采用正交试验法优选白芷、当归和紫草三味中药的提取方案。 3、以辣椒中辣椒素的含量为指标，采用正交试验法优选辣椒的提取方案。 4、以红花中芦丁的含量为指标，选取乙醇的浓度、乙醇的用量、乙醇的流速为考察因素，进行了3因素3水平的正交试验，采用正交试验法优选其渗漉提取的最佳工艺。 (二)软膏的调配 对软膏中所用基质的种类、每种基质的用量，油相和水相的比例，调制的湿度及方法等方面，进行了多次试验比较，以研究得到最佳的软膏的调配方法及疗效。 完成了制备工艺后，本课题对防茄软膏的原料药和成药进行了薄层色谱定性和高效液相色谱定量的研究，采用了薄层色谱法鉴别制剂中的赤芍、桂枝、防已、白芷四味药材，结果表明薄层色谱斑点清晰，特征性强，重现性好，阴性无干扰。采用HPLC法测定了制剂中的白藜芦醇苷的含量，制定了其含量限度。 本课题还进行了防茄软膏的主要药效学及毒理学试验，并进行了初步的临床试用，研究结果表明，防茄软膏制备工艺合理，质量稳定，安全有效，是一种治疗湿疹的很好的药物。更多还原

【Abstract】 Fang Qie Ointment is a kind of pure Chinese materia medica preparation wit hout any hormone. It origins from Pyocutaneous Disease and such effective medical prescription .we made it appropriately on the basis of Chine se medical pharmacologic and experience. The medicine list on the pr escription all recorded in <Chinese Medical> . Cream is also a u sually used dosage form, This paste is special and creative, mainly u sed to threat Eczema and get unique curative effect. Although there are many medicine to treat this disease internal at present, such a Fluonid Ointment Hua Tuo Ointment Pi Yan Ping Ointment , Qu Yan Song Oint ment and so on. The clinic investigation shows that the curative effe ct below the mark, easily to recur after use and cannot heal, from th is , there is still no special medicine to cure Eczema.As the successful development of our medicine, It will fill the tr eat blank internal an aboard.The attack rate of Eczema is higher than others, children is 95 percen t, the adult is about 12 percent . the raw material of this medicine is the no harm and cheap, the market outlook is broad, the expect ec onomic and social revenue is uncountable.The purpose of this project is to study the preparation procedureand quality control standards of Fang Qie Ointment. After reading and studying amounts of Chinese Medical documents, depending on the proof of clinic professors, we choose ointment as the dosage form, dealswith the preparation procedure. Quality standards and stability, formulate the paste and preparation methods of Fang Qie Ointment. We also work out the strictly quality control ways and standards during the process. Primary preview its acute toxicology and medical effects and initial probation in clinic, the concrete content state below.This project studied the preparation procedure of Fang Qie Ointmen t, tried to find the available proposal by orthogonal test. It mainl y divided into two steps. A. The preparation procedure :1. Using dry extract content and Rsveratrol , the special ingredie nt in Polygonum Cuspiclatum as index, design the alcohol-reflux preparation procedure of Stephaniae Tetrandrae , Polygonum Cus piclatunu Paeoniae Rubra Angelicae Sinensis and so on. Us in g the alcohol density, reflux time, reflux times, and the alcoh ol amount as the research factors, the optimum preparation pro cedure of was studied by orthogonal text. The reasonable and available process conditions were established.2. using the imperator in content of Angellicae Dahuricae as index,developed an optimal process of Angellicae Dahuricae, Angelic e sine sis and Lithospermi.3. Using the Capsaicin content in Capsicum anrunm as index. Design the best preparation procedure of Capsaicin.4. Using the Rutin content of Carthamus Tincterius L. as index, design the best preparation procedure of Carthamus TincteriusL. B. Make ointment :After many experiment comparative, the group qualitative beautiful match ratio The degree and the ways to research the perfect degree and effect of ointment.After research for its preparation procedure, we also work out th e strictly quality control ways and standards by TLC and HPLC during the process, the experiment proved that the stability , recovery, r eproducibility and accuracy are satisfactory . Primary preview its cute toxicology and medical effects and initial probation in clinic, The concrete content state below, valuable results were obtained, th e pharmacy study and research of Fang Qie ointment indicate, its pre paration procedure is reasonable ,quality is steady , safety and ef fective. It is a preferable compound preparation to prevent and ther apy Eczema.更多还原