复方抗感颗粒的药学部分研究

【作者】 邹亮；

【导师】 付超美；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2004， 硕士

【摘要】 复方抗感颗粒是由柴胡、荆芥、白术、香薷及翼首草等五味中药制成的复方制剂，具有祛风散邪，化湿和中，清热止痛的功效。主要用于上呼吸道感染引起的发热恶寒、头疼身痛，咽喉肿痛等症。本课题以传统中医药理论为指导原则，运用现代制药技术，对该颗粒剂进行了临床前药学部分的研究工作。 根据临床用药的需要，结合处方用药的性质，确定剂型为颗粒剂。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制备工艺条件为：柴胡、荆芥、白术及香薷等四味药材加水12倍量，提取挥发油5小时，收油率约为0.42％；所提挥发油每1ml用6gβ—环糊精，80ml水超声30分钟进行包合；药液滤过，滤液备用；提取挥发油后的药渣加水煎煮两次，每次加10倍量水，煎煮0.5小时；翼首草采用75％乙醇回流提取3次，每次加8倍量，提取1小时；醇提药液直接用400目滤布滤过，水提药液采用高速离心(8000r／min)进行分离；减压浓缩至相对密度约为1.10(60℃)的浸膏，再采用喷雾干燥和沸腾制粒技术进行干燥和成型。然后对该制剂进行了质量标准研究，确定了以HPLC法测定该方君药柴胡所含芦丁的含量，并建立了相应的测定方法和含量限度，同时对方中柴胡、荆芥及白术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】 Compound Kanggan granules is a new compound preparation of Traditional Chinese Medicine, which consists of Herba Bupleuri, Herba Schizonepetae, Rhizoma Atractylodis Macrocephalae,Herba Moslae and Herba Pterocephali.It has the function of dispelling wind-evil, dispersing pathogenic factors, eliminating dampness, harmonizing stomach and spleen, clearing away heat and alleviating pain.Therefore It can be used to cure such symptom as fever, aversion to cold, headache and bodily pain, throat swelling and pain because of the upper respiratory tract infection.With the guidance of the theories of Traditional Chinese Medicine, Compound Kanggan granules was studied on pre-clinical pharmacy with modern pharmaceutical technology. For the demand of clinic, the form of drug was chosen as granules. On the basis of the function and treatment as well as the characters of the component of the herbs, the optimum extract conditions about alcohol-extract and water- extract were selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. Meanwhile,the extract of volatile oil and the combination of B -cyclodextin with it have been completed. After that the quality standard of the Compound Kanggan granules was finished. Determine the content of Herba Bupleuri in Compound Kanggan granules by RP-HPLC. Use TLC to identify Herba Bupleuri, Herba Schizonepetae and Rhizoma Atractylodis Macrocephalae. 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