Study On The Quality Standard Of Yinhua Influenza Granules

Yinhua influenza granules by the Jinyinhua, Lianqiao, Jiegeng, Gancao, Fangfeng five kinds medicine made with clearing away heat and toxin, relieve sore throat effect. Clinically used for the treatment of fever, headaache,sore throat and other symptoms. Yinhua influenza granules is based on the ancient generation of Yinqiaosan, obtained by prescription and dosage form change, ensure the original effect and the additional check pain. This paper screened the best preparation to clean up influenza granules, determine its quality standards, stability studies.First of all, the quality standard is studied, and the identification, examination and content determination are done. Thin layer chromatography was used for identification of preparation of honeysuckle, forsythia, Glycyrrhiza uralensis, Platycodon grandiflorum four kinds of traditional Chinese medicine, in addition to Platycodon grandiflorum, the existence of negative interference, the other three kinds of traditional Chinese medicine results show that TLC spots were clear and easy to argue, good repeatability, without the interference of negative control. The TLC of three herbs honeysuckle, forsythia, licorice yinhuaganmao granules into the identification of the quality standards. To establish HPLC method for determination of three components of honeysuckle main effective components of chlorogenic acid, Radix sileris mainly effective components of prim-o-glucosylcimifugin,5-O-caffeoylquinic methyl, ammiol glycosides high phase liquid.Chromatographic conditions of chromatography method for content determination of chlorogenic acid by high performance liquid chromatography column:Dima C18(5m, 4.6*200mm). The mobile phase acetonitrile-0.4% phosphoric acid solution (13:87). The detection wavelength:327nm. The flow rate:1ml/min, and the method for the determination of chlorogenic acid content in study, to prove that the method is accurate degree is high, good stability, and can be incorporated into yinhuaganmao granules quality standard of content determination. This method was used to determine the Yinhua Ganmao granule; quality standard of limitation of index for each bag containing chlorogenic acid (C17H24O10) shall not be less than 43.4mg.Chromatographic conditions of chromatography content prim-o-glucosylcimifugin,5-O-caffeoylquinic methyl glycoside, ammiol high performance liquid chromatography column:Dima Ci8(5m,4.6*200mm). The mobile phase of methanol acetonitrile water is 30:15:80. The detection wavelength of 254nm. The flow rate:1ml/min, and the prim-o-glucosylcimifugin,5-O-caffeoylquinic methyl, ammiol glycoside content determination method for study, and the result showed that the method is high accuracy, good stability, can be included in yinhuaganmao granules quality standard of content determination. This method was used to determine the Yinhua Ganmao granule; quality standard index limit for each bag contains total C22H28O10 cimicifugoside C22H28O11 and 5-O-caffeoylquinic methyl Weiss AMI alcohol glycosides should be not less than 6.9mg.On the basis of granules the granules under the relevant provisions of the inspection, including properties, moisture content, particle size, solubility, differences in the amount and also to examine the preparation of heavy metals, arsenic salt, microbial limit, check items are in conformity with the provisions.Secondly, the study on the stability was test, in accordance with the requirements and yinhuaganmao granules were preliminary stability test and accelerated stability test, conducted six months and appearance, the differential and content detection. The results showed that the granules had good stability under the condition of packaging and storage.Through establish TLC identification and content determination, enhance the honeysuckle Ganmao Granule on quality control methods and evaluation index, for the development of a solid foundation for the more perfect the quality standard.