The Studies On Quality Control Of Zidianning Capsule

Zidianning capsule is used to treat ITP as a type of 6th new drug.of TCM.But It is lack of quality standard system because it is in the study stage at present.This paper aimed at establishing the quality standard by TLC and HPLC,and controlling the technics'stability by Chromatographic fingerprint.1.Studies on quality standard of Zidianning capsule. Objective: to establish quality standard of Zidianning capsule. Method: Herbs in preparation were identified by TLC and AstralosideⅣwas determinated by HPLC-ELSD.Results: Methods were established to identify the herbs and qulify AstralosideⅣ.AstralosideⅣhad good linearity in the range of 1.0016-25.04μg (r=0.9999).The average recovery was 100.18 %.(RSD=3.40%).Six pitch samples were determined as 117,127,127,125,126,124μg /pill.Conclusion: This method can be used to control the quality of Zidianning capsule.2. Studies on HPLC fingerprint of Zidianning capsule. Objective: To control technics'and quality'stability of Zidianning capsule by establishing HPLC fingerprintMethod: Chromatographic conditions included Hypersil BDS C18 column and the mobile phase composed of a mixture of methanol and water (contains 0.1%phosphoric acid) (gradient elution) and detection wavelength at 203nm. The mobile phase flow rate was 1.0mL·min-1Results: HPLC fingerprint of Zidianning capsule. was established and was justified feasible by method testing.It can be used to judge if the sample was qualified. in indications of peak number,relative peak area,similarity.Conclusion: The method can provide more information for the quality control of Zidianning capsule. 3.Determination of Shikonin andββ-dimethylacrylalkannin in Radix arnebiaeObjective: To develop a RP-HPLC method for determination of Shikonin andββ-dimethylacrylalkannin in Radix arnebiae.Method: Shikonin andββ-dimethylacrylalkannin were separated on Hypersil C18 column(250 mm×4.6 mm,5μm) and detected at 516 nm by using Acetonitrile—H2O—HCOOH(680:320:5) as the mobile phase, at flow rate of 1.0 mL·min-1.Results: Shikonin andββ-dimethylacrylalkannin had good linearity in the range of 0.0711～14.255μg (r=0.9999) and 8.71～174.5μg (r=0.9999) respectively. The average recoveries were between 95-105.0 %.Conclusion: This method is rapid, simple and accurate for quantitative analysis of Radix arnebiae.