Study On The Determination Of Quality Control Method And Metal Elements Of Yuanhu Zhitong Capsule

Yanhu Zhitong Capsule has been listed in Chinese Pharmacopoeia(2010) and Chinese Pharmacopoeia(2015).Yanhu Zhitong Capsule, is conposed of Corydalis Rhizama (yanhusuo) processed by vinegar and Angelica dahuricaedahuricae Radix (baizhi). Yanhu Zhitong Capsule is widely used due to its excellent effect on therapying gastralgia, costalgia, headache and dymenorrheal by promoting qi and blood circulation.At present, only a few bioactive components are chosen to assess the quality of Yanhu Zhitong Capsule so that the quality assessment could not effectively complete and comprehensively reflect its quality.Therefore,in our work, according to the quality standard of Chinese Pharmacopoeia(2015), we improved its quality standard. A comprehensive quality evaluation system of Yuanhu Zhitong Capsule was established based on the previous quality standard of Yuanhu Zhitong Capsule from different manufacturers. The main results of our work were as follows:1. Study on quality standards of Yanhu Zhitong CapsuleThe separation conditions of TLC identification were improved. The reference substances include tetrahydropalmatine, imperatorin and isoimperatorin. The reference herbs include Corydalis Tuber and Angelica dahuricadahurica.The contents of tetrahydropalmatine, imperatorin and isoimperatorin in samples from different manufacturers were determined with the improved HPLC method. The results indicated that there were great differences in contents of three active components from different manufacturers. The importance and significance of extracts as one of the routine inspection item for the Chinese traditional medicine quality control was further confirmed.2.Study on HPLC fingerprint of Yanhu Zhitong CapsuleThe method of HPLC fingerprint for Yanhu Zhitong Capsule was established based on different herbs involved. There were 9 common peaks in the fingerprints. The HPLC fingerprint overcomes the shortcomings of TLC and can evaluate the stability of raw materials and production process objectively. Through the comparison of HPLC fingerprints of formula medicinal materials in Yuanhu Zhitong Capsule we found that high similarity was shown in Corydalis Rhizama, while apperant differences occurred in some peak areas. However, there were great discrepancies in quality of Radix Angelica dahuricaedahuricae.3.Study on heavy contained in Yanhu Zhitong CapsuleTo investigate the contents of heavy metals and harmful elements in Yuanhu Zhitong Capsule, the contents of heavy metals and harmful elements (Pd,Cd,As,Hg,Cu and Cr) in Yuanhu Zhitong Capsules were determined by AAS and AFS. The amount of Pd,Cd,Cu are exceed the limits in different degree, while the amounts of As,Hg and Cr are in the limit required. The present quality standard of Yuanhu Zhitong Capsules should establish the corresponding method to limit the amount of heavy metals and harmful elements (Pb,Cd,As,Hg,Cu and Cr). This method to determine the contents of heavy metals and harmful elements would be good reference for quality and safety evaluation of Yuanhuzhitong Capsule.The present method was simple, convenient and high sensitivity. The quality control method and evaluation system of Yuanhu Zhitong Capsule would be further improved based on our present work, and will provide a more reasonable guarantee for the clinical use of this preparation.