Epilepsy Flat Piece Of Quality Control And Evaluation Standard Research

Dianxianping Pian is one of modern Compound preparation of TCM,which is made from Acori tatarinowii rhizome and Stiff Silkworm etc.Its Standard has been recorded in Chinese local standard to rise the national drug standard part (Internal Medicine Department of the brain main and collateral channels limb fascicle).In this standard, there are only TLC identification of Acori tatarinowii rhizome and Paeoniae radix alba and content determination of paeoniflorin.The original standard has very few identify and specificity and quality controllability is poor.So it was listed in the study of national drug standards improve action plan. NO.48. In this task, index component that was used for qualitative and quantitative study and fingerprint were used as research method.In this study,the quality standard of Dianxianping Pian had been systematically studied, which provides the basis to the quality control of Dianxianping Pian. The main research contents are as follows:1.Basic research of Dianxianping Pian quality standard has been done.To determine the establishment of identification and content determination of pharmaceutical based on analysis of prescription prescription and prescription dose. Study on quality standard of raw materials and accessories in order to ensure stable quality of raw material. Prescription medicinal research reviews that provide basis to the selection of qualitative and quantitative index component.Preparation process analysis,which confirmed the feasibility of index component selection.Research preparation of Dianxianping Pian quality standard, including raw materials, product, standards;as well as negative control samples.2.Systematic and in-depth study of Dianxianping Pian quality standard had been done.(1).Methodology test of original standard including TLC and micro-identity of Acori tatarinowii rhizome and TLC identification of Paeoniae radix alba and content determination of paeoniflorin which metastasis rate and limit of content were studied. (2).TLC identification of Gleditsiae fructus abnormalis and Bupleuri radix had been added to the new standerd.This method proved to be feasible has good specificity and reproducibility through methodology research and validation.(3).The content determination method of β-asarone in Rhizoma Acod Talarinowii by HPLC has been established. The results of HPLC showed that a good linearity was in the range of0.212μg-2.65μg(r=0.9999), and the average recovery was96.7%, RSD=1.08%, mobile phase was methanol-water(65:35). The method is simple and reproducible,and can be used for the quality control of DianXianPing Pian.3.In order to improve specificity and sensitivity of the method of the determine-ation,the method for content determination of β-asarone in Rhizoma Acod Talarinowii by HPLC-MS has been established through further research.And mobile phase was methanol-water(65:35),flow rate was0.4ml.min-l,the detection wavelength was252nm,and using positive ion mode,the linear range was0.125ng-1.25ng (r=0.9988),the rate of recovery was96.2%.β-asarone had been identified in this method that is accu-rate and feasible,and has good repeatability.At the same time,this method is a test to HPLC4.The fingerprint analysis method of volatile constituents in Dianxianping Pian was established. Through the fingerprint analysis of12batches of different batch number of Dianxianping Pian sample and batch rhizoma acori graminei, we develop-ed the standard fingerprints of Dianxianping Pian.Volatile oil was extracted by steam distillation,and using DM-17capillary column,splitless sample injection, temperature programmed:initial temperature80℃,keeping3min,rise to150℃by the rate of3℃.min-1,keeping2min,rise to230℃by the rate of5℃,keeping4min.The national pharmacopoeia committee"The similarity evaluation system of chromatographic fingerprint of TCM2004A"software wae used to analyse the volatile oil in12batch of different batches of Dianxianping Pian.And it has higher similarity, the fingerprint method is simple, reproducible.It can be used as reference for the quality control of the raw materials and product.5.New quality standards of Dianxianping Pian was established.In the new standard,the prescription, preparation method,Characters didn’t been modified,TLC identification of Gleditsiae fructus abnormalis and Bupleuri radix had been added to the identification.In determination items,the content limit of paeoniflorin was revised, the content determination of B-asarone was added.The remaining portion didn’t been modified. And the new standard is conform to requirements by review.This study shows that the quality standard of Dianxianping Pian is perfect,scient--ific and feasible and reliable.it can provide a more accurate and efficient basis for the quality control of Dianxianping Pian.