Fingerprinting Method Study On Quality Control Of Rupixiao Soft Capsule Extracts

The complex Chinese herbal formula Rupixiao was an clinical prescription. It wascomposed of fifteen kinds of herbs, including antler, notoginseng radix, flos carthami,and so on, it was used to treat hyperplasia of mammary glands. The tablet and capsuleformulas of Rupixiao were absorbed in Pharmacopoeia of the People’s Republic ofChina(2010)Ⅰ.In this article, the quality of Rupixiao sofe capsule extract has beenstudied in order to ensure its safety and effectiveness.The contents of Rupixiao soft capsule were extracted by the new technology forthe whole part, and the main active constitutents were polysaccharides, flavonoids andsaponins. In this article, the quality control method of Rupixiao soft capsules extractincluding the Rupixiao prescription medicinal chemical compositions were got byliterature inspection; the HPLC fingerprint of Rupixiao was established; and medicinalingredients in Rupixiao extract fingerprint were qualitative identificated by MS. Themain contents include:According to the inspection results of the literature, the database which wascontain the main active compositions of Rupixiao and the chemical compositions of afull15flavor herbs was established based on the results of literature review. Provide abasis data reference for the later fingerprint research on this topic.In the study of fingerprints of the extract of Rupixiao, macroporous resinadsorption process was used to preparation the extracts. In order to maximize thequantitative information of chemical ingredients from the fingerprint, select the twowavelengths of275nm and210nm as detection wavelengths from the DAD detectorscan results in this article. The results show that, the10batches Rupixiao macroporousresin extract samples with the reference fingerprint similarity calculation results aregreater than0.9. Combined with Rupixiao and the herbs’ fingerprints, mass spectrometry inspectionknowledge, the representative components were identified from fingerprints by thecorresponding reference substance.Chromatographic fingerprint analysis method can be used to control Rupixiao softcapsule preparation process and quality stability, and ensure different batches ofproducts quality stability, and uniformity.