Study On The Quality Standard Of Notopterygii Rhizoma Et Radix

Objective:It is hard to accurately and completely control the intrinsic quality of Notopterygii Rhizoma et Radix, because there are only the characteristics, extractives and the content of volatile oil in the Chinese pharmacopoeia (2005 edition, volumeâ… ), but without the items including total ash and acid-insoluble ash, TLC identification, determination of representative component. Therefore the improvement and elevation for the quality standard of Notopterygii Rhizoma et Radix should be further made. And this study aims to draw up quality standard draft of Notopterygii Rhizoma et Radix through deeply and systematically studying. Methods:(1) The reference substances were extracted and separated from Notopterygii Rhizoma et Radix by silica gel column chromatography. (2) The chemical constitutions of reference substances were identified by NMR, MS, and so on. (3) The purity of reference substances were tested by TLC and normalization method of HPLC. (4) Total ash, acid-insoluble ash and the content of volatile oil were detected by the ChP. method and Notopterygii Rhizoma et Radix was identified by TLC. (5) The contents of main components in Notopterygii Rhizoma et Radix were dertermined by HPLC. (6) Similarity evaluation system for chromatographic fingerprint of TCM (2004 AB) was used in data analysis on fingerprints of Notopterygii Rhizoma et Radix. Results:(1) The purities of notopterol, isoimperatorin and nodakenin were more than 98 percent. (2) Results showed that total ash and acid-insoluble ash of Notopterygii Rhizoma et Radix fluctuated from 4.03% to 7.40%, from 0.33% to 3.39%. Therefore the total ash and the acid-insoluble ash not more than 8.0% and 4.0% could be tentatively given. (3) Based on volatile oil fluctuating from 1.12% to 2.92% and the average content 2.01%, the volatile oil not less than 1.4%(ml/g) could be tentatively given. (4) TLC spots were different between Notopterygium incisum Ting ex H. T. Chang and Notopterygium franchetii H. de Boiss., then the standard herbs was not suitable for TLC. Because nodakenin was common to two sources, it had been used to identify Notopterygii Rhizoma et Radix with TLC. (5) In Notopterygium incisum Ting ex H. T. Chang, the content of free ferulic acid fluctuated from 0.120% to 0.303%, while total ferulic acid from 0.694% to 1.122%. And in Notopterygium franchetii H. de Boiss., the content of free ferulic acid fluctuated from 0.017% to 0.131%, while total ferulic acid from 0.185% to 0.753%. So it was obvious that ferulic acid existed mainly by means of conjugation in Notopterygii Rhizoma et Radix. In addition, the content of nodakenin fluctuated from 0.0057% to 1.558% in Notopterygium incisum Ting ex H. T. Chang, while from 2.307% to 3.049% in Notopterygium franchetii H. de Boiss.. The content of nodakenin had significant difference. On the other hand, ferulic acid was lack of specificity, and notopterol contents were lower in some Notopterygium franchetii H. de Boiss., while the isoimperatorin contents were higher, which complemented, also the amounts were higher, so the amounts of notopterol and isoimperatorin were used as the index of determination. On base of the amounts (calculated with reference to the dried drug) fluctuating from 0.37% to 1.88% in 15 batches of Notopterygii Rhizoma et Radix, the amounts of notopterol and isoimperatorin not less than 0.4% could be tentatively given. (6) The HPLC fingerprints were established on Notopterygium incisum Ting ex H. T. Chang and Notopterygium franchetii H. de Boiss., which were marked 42 common peaks and 30 common peaks, respectively. Comparing the HPLC fingerprints of Notopterygium incisum Ting ex H. T. Chang with the HPLC fingerprints of Notopterygium franchetii H. de Boiss., the results indicated there was significant difference between them. Conclusion:The notopterol,isoimperatorin and nodakenin reference substances have been got, and the quality standard of Notopterygii Rhizoma et Radix has been improved and elevated, consisting of adding TLC identification item, the detection item of total ash and acid-insoluble ash, revising the determination item of volatile oil, adding the determination item of notopterol and isoimperatorin amounts with HPLC. Finally, a quality standard protocol of Notopterygii Rhizoma et Radix has been formed. After approved by Chinese committee of pharmacopeia, the protocol has been recorded in Chinese pharmacopoeia (2010 edition).