Studies On Quality Standard And Fingerprint Of Qingkailing Injection

As a kind of national protected traditional medicine ,Qingkailing injection consists of eight components as cholic , fructus gardeniae, flos lonicerae japonicae, etc. The complexity of its chemical constitution made the requests of quality standard on injection too strict for the current preparation technology .The abundance of untoward reaction cases indicates that under the precondition of improved artwork, the establishment of quality standard is significant to safe medication.To establish the quality standerd of the Qingkailing injection made from ultrafiltration of ceramic membrane , HPLC methods for cholic, baicalin and geniposide determination are established, the comparison of the ultrafiltration process and traditional process proved the product of the new preparation technology safe and controlable.The fingerprint of Qingkailing injection was made under the direction of《Technique requirement of traditional Chinese injection medicine fingerprint (temporary)》, the HPLC parameters were determined according to the feature of each component .By the means of preparation chromatography ,the wavelength procedure installation was determined according to the retention time of each component in the column and the whole information was expressed in good details . Total of the 14 common peaks were determined as characters of the map . The relationship of the shared peaks between Qingkailing injection and standard medicinal herbs confirmed the absorptive peaks specific for chlorogenic acid, baicalin and geniposide. Repeated verification experiments proved the whole way accurate ,stable and reliable.The similarity evaluation system for chromatographic fingerprint of TCM was used to ten batch samples. The results of evaluation were that every batch similarity was over 0.9, conforming to the requirements of TCM preparation.