The Quality Of Nvjin Pill

Nvjin pill is a traditional Chinese medicine, which is from the Ming Dynasty,《Jing Yue Quan Shu》.The large honey pill or water honey pill is made up of 23 Chinese herbal medicines such as Chinese Angelica, Szechwan Lovage Rhizome, Peony Root, Rehmannia Root, Cinnamon Bark,Corydalis Tuber,Amomum Fruit, Scutellaria Root,with regulating qi and promoting blood circulation,benefiting qi for activating blood circulation and relieving pain effct.Treat irregular menstruation that caused blood stasis due to qi stagnation, deficiency of both qi and blood, drugs commonly used to gynecological.Though current quality standard of nvjin pill has been embodied in the first part of CP2005, the specification only includes identifications of one ingredient by microscope and of three other ingredients by TLC method. For these identification methods, there is still room for improvement. For example, the specificity of microscope method for identification is not good; a large amount of organic solvents is used in the extraction of paeonol; benzene is used as developing solvent for the identification of cinnamaldehyde, which is not allowed for its high toxicity; reproductively of identification method for baiceline is not good. At the same time, there is no quantitative control indicators.The requirements of the times and environment's change must constantly improve the level of Chinese herbal medicine quality control. Therefore, the quality of Nvjin pill has been studied, which mainly includes:The preparation of peaonol and cinnamaldehyde sample has mainly been changed in TLC and the volatile oil extraction is instead of ether extraction. At the mean time, cinnamaldehyde's original developing agent is replaced by petroleum ether (60(?) 90℃)-ethyl acetate (17:3). Identifying method of baicalin has been revised and macroporous resin column and polyamide column is used together to separate baicalin. We also established TLC methods for the identification of Corydalis Tuber, Dried Tangerine Peel, Paeoniflorin, motherwort. Corydalis Tuber is extracted with chloroform, and impuritied by acid-base repeatly extraction; Stachydrine hydrochloride is separated with 732 strong acid cation exchange resin; hesperidin is extracted by ethyl acetate and paeoniflorin by n-butanol.The HPLC method for determination the hesperidin in Nvjin pill has been established. The best chromatographic separation condition are:the C18 column is a 6.0×150mm Shim-pack VP-ODS with 5μm particles, the mobile phase is 0.1% phosphoric acid: Methanol:acetonitrile(12:13:75), and the flow rate is 1.0mL/min,the detective wavelength is at 284nm. Validation tests are done for the method and the results shown that established method have good accuracy, precision, reproducibility(RSD= 0.3%) and the hesperidin shows a good linear relationship in the range of 0.01968～4.92μg, y=1754279x+4145.9, r=0.9999. The method is simple, accurate and can be applied to the quality control of preparation.As a result of this research project, revised Nvjin pill standard has been set by 2010 edition of Chinese Pharmacopoeia.