Study On The Quality Control Method Of Fingerprint Of Liuwei Dihuang Pill And Its Related Preparations

Liuwei Dihuang is a famous Chinese formula which was used for thousands years to treat the “kidney-yin” deficiency syndrome under TCM prescriptive terms,includes symptoms of soreness of the loins and the limbs, dizziness, tinnitus, and sweating. The formulation consists of six Chinese herbal ingredients, Radix Rehmannide Preparata, Rhizoma Dioscoreae, Fructus Corni, Cortex Moutan,Rhizoma Alismatis, and Poria. Modern pharmacological studies have shown that the formulation is effective in maintaining neuroendocrine immunomodulation balance,improving cognitive function, and improving or restoring the symptoms associated with aging and geriatric diseases. As a formula with definite clinical effect, Liuwei Dihuang has many type of preparation and many manufacturers due to it's huge market demand. However, it' s quality control methods are insufficient. Our research developed quality control methods in dual-wavelength fingerprinting mode, aim at supporting quality control and scientific research into the pharmacological potential for these formulations.First, we summarized constituents in single herb and formulations and the current quality control methods from the aspect of general identification,fingerprinting, determination of harmful metals. After that, a high performance liquid chromatography fingerprinting method of Liuwei Dihuang pills was developed.Though this method, 20 samples from different manufacturers of Liuwei Dihuang pills were analyzed by similarity analysis, and the quality difference was obtained.Second, an ultra high performance liquid chromatography in dual-wavelength fingerprinting mode was obtained. By comparison with the standards, the eleven components were identified, they are gallic acid, protocatechuic acid, 1, 2, 3, 4,6-o-pentagalloylglucose, paenol, 5-hydroxylmethyl furfural, morroniside, loganin,sweroside, paeoniflorin, benzoic acid, benzoylpaeoniflorin. This method can simultaneously determine above 11 components within 9 minutes. This robust approach provided a fast and comprehensive quantitative determination of the major bioactive markers within Liuwei Dihuang preparations. To distinguish four dosageforms of Liuwei Dihuang preparations, a random forest technique was applied on the spectrometric fingerprint data obtained. This combination approach of chromatographic techniques and data analyses might serve as a rapid and efficient tool to ensure the quality of Liuwei Dihuang preparations.