Analysis Research On Quality Control Of Liuwei Dihuang Pills

Liuwei Dihuang Pill is a classical recipe in nourishing the kidney and it is widely used for the insufficiency of kidne-yin. It consists of six Chinese herbs including Radix rehmannia, Fructus corni, Rhizoma dioscoreae, Rhizoma alismatis, Cortex moutan radicis and Poria cocos. It can strengthen immunity, anti-aging, anti-fatigue, anti-hypoxia, and lower blood pressure, blood sugar, etc. So the quality control of Liuwei Dihuang Pill on the assurance of its effectiveness is especially important.As notes in 2010 Chinese Pharmacopoeia, its indicators of product quality control are paeonol and loganin, and the methods of content determination are High Performance Liquid Chromatography, although methods with high accuracy, detection strategies use different Liquid Chromatography, making the quality control time-consuming, tedious, and easily cause much error by many operation steps. So establishing one method of HPLC for determinating paeonol and loganin simultaneously has important significance. Cortex moutan radicis is an important raw material in Liuwei Dihuang Pill, it firstly extracts paeonol, then paeonol is mainly used in the process of production, unlike other mixed herbs, so the investigation of transfer rule of paeonol in the whole production process is important. Lastly, Radix rehmannia before used must be processed, the content of 5-hydroxymethyl furfural is high, then too much 5-HMF was harm to human body, often as a risk factor for control in the food, for example, in international trade requirement the content of 5-hydroxymethyl furfural in honey is less than 40 mg per kilogram. So at the same time, the research on content of 5-HMF also has important significance for the safety of Liuwei Dihuang Pill.Much work that we done in this paper mainly was the following:1. To establish to a new HPLC method to quantify effective constituents of Liuwei Dihuang Pill simultaneously. In this paper, the quantitative components were paeonol, loganin and 5-HMF, at the same time this method was not only suitable for concentrated pill, but also applied to the other dosage forms, such as small honey pills and water-honeyed pills, etc. This method maked up for the determination shortage that there were two HPLC methods that were applied to determine paeonol and loganin respectively in China pharmacopoeia. The method is accurate, rapid, efficient, and can be used for analysis quality of Liuwei Dihuang Pill.2. we used the above conditions of HPLC to quantify Liuwei Dihuang Pill of different manufacturers in different dosage forms, to look these results were whether according with requirements of Chinese pharmacopoeia. We used samples from 33 different manufacturers, totally 46 samples containg different dosage forms of Liuwei Dihuang Pill. Then compared with pharmacopoeia method at the same time, found that there was a lot of advantages, for that the sample preparation conditions was quite simple. This method was used for the analysis of the HPLC fingerprint chromatogram of Liuwei Dihuang Pills which came from 9 manufacturers. Then we compared overdate and indate samples to mornitor the variation of content of three components in the samples.3. To establish a new type of simple quantitative method of liuwei dihuang pill-Ambient ionization mass spectrometry, the quantitative ingredient was paeonol in this paper with the protopine as internal standard substance. We took samples which were related with paeonol during the whole production process, to on real-time observe the change of content of paeonol in the whole process. At the same time, we compared mass spectrometry and HPLC quantitative results, found that the results of the same sample were similar, to illustrate that the Ambient ionization mass spectrometry is feasible, to set up a new rapid and simple quantitative method for Liuwei Dihuang Pill.