aaa喉咽清口服液的质量标准的研究.docVIP

喉咽清口服液的质量标准的研究 李 果 湖南师范大学医学院 2003级药学系 摘要：本标准分别从性状、鉴别、检查及含量测定方面进行系统研究,分别进行考查,同时建立并完善控制喉咽清口服液质量的质量标准。性状是考察其外观性状，鉴别则是根据处方中所含药味特征（如：土牛膝、车前草、天名精等）的成分进行鉴别，检查根据用药安全选择了重金属及砷盐的检查，含量测定项则是运用薄层扫描法（采用CS-930薄层扫描仪及CD-60薄层扫描仪，薄层板：以0.3%羧甲基纤维素钠为黏合剂的硅胶G薄层板，展开剂：环己烷—氯仿—醋酸乙酯（20∶5∶8），显色剂：10%硫酸乙醇溶液，显色条件：105℃加热至斑点显色清晰）根据测定君药土牛膝中的齐墩果酸的含量进行含量项的质量控制并进行方法学研究。经过试验研究证明可行,并能控制本品质量,故建立本含量质量标准。 关键词：喉咽清口服液；质量标准；性状；鉴别；检查；含量测定 ABSTRACT The which controls the quality of Houyanqing Koufuye in character, identification, check and measuring the contents was established. The experiment of character inspects the character of exterior. The experiment of identification is using the ingredient which is characteristic. For example, Achyranthes aspera L, Plantago asiatica L, Carpesium and so on. The experiments of check include the check of heavy metal and arsenic salt. The purpose of measuring the contents using the method of TLCS which based on measuring the contents of radix astragali in monarch drug in a prescription astragalus root is controlling the quality. Following is the TLCS conditions. Instrument: thin layer scanner CS-930 and CD-60.Thin-layer plate: the thin-layer plate of silica gel G using the chemical bond of 0.3 percent sodium carboxymethyl cellulose. Developing agent: normal cyclohexane - trichloromethane - glacial acetic acid(8:1:1). Visualization reagent: 10 percent solution of sulphuric acid ethyl alcohol. The condition of appearance color:105 centidegree heating until the spot appears. According to the characters in the Achyranthes aspera oleanolic acid content of the items in the quality control and research methods In addition, we conduct the research of methodology. This quality standard is feasible by above-mentioned experiments. KEY WORDS Houyanqing Koufuye; quality standard; character; identification; check; measuring the contents  引 言 1喉咽清口服液的药理作用 喉咽清口服液是我国目前用于内科实火证、耳鼻喉科喉痹类非处方药药品清热解毒，利咽止痛。用于肺胃实热所致的咽部肿痛，发热，口渴，便秘，以及扁桃体炎、急性咽炎见于上述证候者微波凝固加喉咽清口服液治疗肥厚性咽炎喉咽清WHO对传统医药必须“安全、有效、稳定、均一