Study On Yigong Capsule And Its Fingerprints

"Yi-Gong-Ning-Xue"(YGNX) oral liquid is a state approved Chinese patent medicine based on a traditional medicine formula. In many years of clinical applicationYGNX oral liquid has displayed such functions as invigoration of vital energy, nourishing YIN, kidney fortification and stopping bleeding, It has been effectively used to treat uterine bleeding and metrostaxis. The original formula of YGNX oral liquid includes such components as Panax ginseng, Radix Fructus Psoraleae, Raidix Ophiopogonis, Coastal Glehnia Root, Radix Polygoni Multiflori, Fructus Ligustri Lucidi, Fructus Schisandrae, Halloysitum Rubrum, Radix Rubiae, Os Sepiae, Herba Leonuri and Radix Glycytthizae. In order to broaden and facilitate use of this traditional Chinese medicine, the current study aims to reform YGNX from oral liquid to solid dosage form and establish methodology for content determination of new dosage form and quality control. Primary pharmacology and finger print of new dosage form are also to be studied.Reformation of dosage form and stability study:Tablet form was initially considered. It was discovered, however, that per tablet dosage was too low after sheeting. Therefore, capsule is chosen as the solid dosage form. Stability experiment showed that three batches of YiGong capsule(YGC) samples had good stability in description, standards of identification, content determination.Quality control analysis of YGC:Through thin layer chromatography,main active ingridients of the medicinal components of the formula, such as Panax ginseng, Radix Fructus Psoraleae, Radix Polygoni Multiflori Preparata and Radix Glycytthizae analysis were identified.HPLC was employed to establish quality standard. Psoralen and isopsoralen are used as standard compound. Chromatography analysis was performed on a Diamonsil C18 analytic chromatographic column (250mm×4.6mm i.d. with 5.0μm particle size). The mobile phase was a mixture of methanol-water-phosphoric acid (53:47:0.2, v/v), and the UV detection wavelength was 246 nm. The established quality standard has high specificity and sensitivity, good reliability.Primary pharmacology of YGC:Anti-fatigue and hypoxia-resistance promoting effects of YGC were tested on normal and immune compromised mice. At the same time, thymus and splenic indices were taken and serum IgG level was measured as indicators of immune function. Bleeding time and in vitro coagulation time were also determined.The results showed that YGC significantly prolonged the swimming time of normal and immunosuppressed mice, as well as their subsisting time in an airtight container under normal pressure. YGC raised thymus and splenic indices and serum IgG level in both normal and immunosuppressed mice. Bleeding time and in vitro coagulation time in mouse was also decurtated.Fingerprint of YGC:The chromatographic separation was performed on a Eurospher C18 column (250mm×4.6mm i.d. with 5.0μm particle size) with a methanol-water gradient containing 0.5% (v/v) aqueous phosphoric acid as mobile phase, the DAD detection wavelength was 225nm. Ascertainment the fingerprint method of YGC and did the test of stability and adaptability. Established the standard fingerprint of YGC and calculated the discrimination coefficient of YGC products' fingerprint to control its quality.All the above had make the control quality of YGC to a whole quantization level and set a paradigm for the complex Chinese medicines' fingerprint at the same time.