Research On Quality Standards Of Flos Trollii

“Research on quality standards of Flos Trollii” is the task of State PharmacopoeiaCommittee undertaken by Pharmaceutical Institute of Hebei Normal University, which isdevoted to improving pharmaceutical standard.Flos Trollii is the dried flowers of Trollius chinensis Bunge, which is derived fromRanunculaceae of Trollius L.. Most of Trollius L. has the effect of broad spectrumantibacterial and antiviral, which can be used on the treatment of respiratory and intestinalinfections. It is one of the rich resources in our country, and its medical value has caused moreand more attention. Today, series of preparations of the Flos Trollii have been developed, butthe early quality control of Flos Trollii is too simple, especially lack the qualitative andquantitative analysis method. According to requirements of State Pharmacopoeia Committeeto medicinal materials collected in Pharmacopoeia of PRC (hereinafter short for ChinesePharmacopoeia), the research is to compensate for the defects of the early quality standards ofFlos Trollii, which is out-of-date and oversimplified in techniques and unperfect in projectstandards. We tend to make practical quality control system of Flos Trollii medicinal materials,which conforms to the modern Chinese medicine standard and technology standard, so as toregulate the development and utilization of Flos Trollii.We have collected22batches medicinal materials from main production areas of ourcountry and5specimens around Taihang mountain area, systematically studied each index ofquality control of Flos Trollii, established a method and standard for evaluating the quality ofFlos Trollii and developed the draft of quality standards for Flos Trollii. We are trying toprovide abundant and objective data and reference for the formulating of quality standards ofFlos Trollii in Chinese Pharmacopoei (the supplement edition in2010). The main contentsand results of the paper are as follows:1The results of the identification of origin on the medicinal materials are as follows:among those medicinal materials, there are16T. chinensis Bge.,4T. macropetalus Fr.Schmidt and2T. ledebouri Reichb.. In addition, we also had characteristic identification andmicroscopical identification of T. chinensis Bge., and established the TLC method of orientinin T. chinensis Bge.. The good separation was taken by using1-Butanol: acetic acid: water （6:1.5:2.5）as the mobile phase, standard medicine and orientin having dual control. Thechromatographic spots were clear and the Rfvalue was moderate. The TLC method isadaptable and reproducible, and can be used as one of the exclusive methods to theidentification of orientin in T. chinensis Bge..2According to the Chinese Pharmacopoei of2010edition, the moisture, total ash, acidinsoluble ash, water-soluble extract, ethanol soluble extraction, volatile ether soluble extract,heavy metals and harmful elements of22batches medicinal materials were checked.Combined with the measured data, actual production and market situation, the limits were setas follows: the moisture, total ash and acid insoluble ash should not be over11%,10%and1%, respectively. Water-soluble extract, ethanol soluble extraction and Volatile ether solubleextract should not be less than34%,15%and2‰, respectively. Cu, Sb, Cd, Pb, Hg shouldnot be over20ug/g,0.9ug/g,0.3ug/g,1.3ug/g,0.2ug/g, respectively.3After systematic analysis of22batches medicinal materials by HPLC method, weestablished the fingerprint of Flos Trollii, and analyzed the fingerprint of Flos Trollii amongdifferent species and a certain specie collected from different areas. The HPLC analysis wascarried on a DiscoveryC18column; the acetonitrile and0.05%formic acid solution in theratio of87:13were used as mobile phases at a flow rate of0.7ml/min-1; the UV detectionwavelength was set at354nm. We also determined the content of orientin in Flos Trollii.According to the measured data, actual production and market situation, the limit of orientincontent was set as not less than0.5%. The HPLC method established in this paper is accurate,with high reproducibility and easy to operate. It provides a scientific new method forevaluating and controlling the quality standards of Flos Trollii.After systematic studied on22batches medicinal materials, we formulated the limits ofwaters, ash, abstracts and heavy metals, increased the safety index of Flos Trollii. In addition,we established the fingerprint of Flos Trollii and the method of determining the content oforientin. From both qualitative and quantitative aspects, we perfected the study on qualitystandards of Flos Trollii.