Epimedium Herbs And Xianlinggubao Of Capsule Quality Standards To Enhance The Research

Produced by Guizhou Tongjitang Pharmaceutical Co., Ltd , Xian-ling-gu-bao capsule (Epimedium as the highest contenting medicine ), a famous medicine was widely used to treat osteoporosis diseases, which has made a dramatically output of RMB 0.5 billion yuan in the year of 2008. Epimedium brevicornum Maxim., E. -sagittatum(Sieb. Et Zucc.)Maxim., E. pubescens Maxim., E. wushanense T. S. Ying, E. acuminutum Franch., E. 1eptorrhizum Steam.and E. koreanum Nakai, Yinyanghuo in Chinese, are commonly used in Traditional Chinese Medicines (TCMs). Epimedium is widely distributed in most provinces of China and Guizhou province is the major producing region.Flavonoids are considered as its major active components in the herb Epimedium, which have been reported possessing multiple biological activities, such as antiosteoporosis, immunological function modulation and anti-tumor actions. The major substances of flavonoids are two materials with similar chemical structure and biological activity as: icariin and epimedin C. While, the chemical structure of the latter has only one more rhamnosyl than that of the former. Since the reference substance of epimedin C (content≥98%) has not been successfully prepared , only icariin can be used as marker substance for the quality control of Epimedium and the Epimedium contenting products. For the better quality control of Epimedium and the herbal preparation Xian-ling-gu-bao capsule, epimedin C should be also used as marker substance.In order to make a better method to control the quality of Epimedium and Xian-ling-gu-bao capsule. On the basis of making and preparing qualified reference substance of epimedin C (content≥98%) , with epimedin C and icariin as its double marker substance, a content measure method for Epimedium and Xian-ling-gu-bao capsule were set up. With this new method, 76 Epimedium samples and Xian-ling-gu-bao capsules were measured. This research result provided a more suitable, comprehensive, and accurate way for measuring Epimedium contents. Moreover, it is also easy, quick, precise and reproducible. If this method was accepted by Chinese Pharmacopoeia Commission and other departments, it will not only improve the quality standards of Xian-ling-gu-bao capsule and Epimedium, but also can make some unqualified contents of icariin but qualified contents of icariin and epimedin C of Epimedium available. It will enlarge the source of Epimedium and help relieve insufficient source of Epimedium for preparing of Xian-ling-gu-bao and other Epimedium contenting national medicines.Moreover, for the better quality control of Xian-ling-gu-bao capsule, the chromatographic fingerprint of Xian-ling-gu-bao were developed, through the High Performance Liquid Chromatography (HPLC). Tweleve batches Xian-ling-gu-bao capsules provided by Guizhou Tongjitang Pharmaceutical Co., Ltd. were used to establish the fingerprint. Six compounds of the capsules were identified through a Liquid Chromatography-electrospray Ionization Mass Spectrometer (LC-MS) and the HPLC peaks of the two herbs, E. wushanense, (Yinyanghuo in Chinese) and Psoralea corylifolia (Buguzhi in Chinese), could be recognized from the HPLC common peaks of the capsules by comparing the peaks of every herb composed of the capsule and those of Xian-ling-gu-bao capsule and it also provided the sciencetific basis for promoting quality standards of Xian-ling-gu-bao capsule.