Research On Contrapositive Pieces Of Typhonii Rhizoma

In current Chinese Pharmacopoeia, the standard materials to control the quality of Chinese Medicine Pieces (CMP) are crude reference material, chemical reference substance, reference extract. However, these standard materials can not fully reflect the characteristics of CMP, especially its scientific connotation and feature properties. Therefore, based on the analysis of the existing quality standard problems of Typhonii Rhizoma pieces, this work start to establish contrapositive pieces to explore the quality control method of CMP.Firstly, research of production place. Collecting raw material with good quality of original production place and different batches of Typhonii Rhizoma (TR) pieces in market. We know local planting and processing technical specification of Yubaifu and the current main processing methods, which provides foundation and basis for further research.Secondly, research on homogenization processes of TR contrapositive pieces. Three batches of raw and processed TR pieces are prepared by new Lotus company, respectively. Pulverization time of the raw and processed TR pieces were obtained by sieving method using a filter system. The optimum particle size of raw and processed TR contrapositive pieces were achieved by using the thin layer chromatogram as the marker. And by using HPLC, TLC and colorimeter the chemical components and appearance uniformity of color of the as-prepared pieces were evaluated. The results showed that screened homogenization technology is feasible, which could ensure that the internal components of the powder and the appearances of color were uniform.Thirdly, the work analyzed the contrapositive pieces and commercial pieces by adopting the conventional analysis method of current edition pharmacopoeia, on the basis of this analysis results, methods of determination of organic acids and residual amount of alum in TR contrapositive pieces was established. And the quality evaluation standards of the raw and proceeding TR contrapositive pieces were developed.Finally, the change regular of the crude polysaccharides, total saponins, total amount of organic acid, and the residual amount of alum in raw material, pieces and contrapositive pieces of TR were evaluated, and the change regular of their characteristic spectra of HPLC and TLC between the above three materials were also investigated. The experimental results indicated that there was almost no difference in the contents of the chemical composition and the characteristic spectra between pieces and contrapositive pieces, suggesting that the as-prepared TR contrapositive pieces can be used for its quality control. In addition, the influence factors of its quality stability were also obtained by preliminary tests.In summary, this work was first to study on TR contrapositive pieces, and relatively complete quality evaluation standards for the identification of raw and processed TR contrapositive pieces were established respectively. The results suggested that the as-prepared contrapositive pieces can be utilized as the reference, which could benefit the further scientifically and reasonably quality control of TR pieces. This research provides ideas for quality control methods of CMP. It also helps promote and accelerate researching on the quality control method of CMP, and gradually improve quality standard system of Chinese medicine.