Studies On Quality Standard Of Corydalis Decumbentis Rhizoma Extract

“Xiatianwu”, family Papaveraceae, is the rhizome of Corydalis decumbens(Thunb.) Pers. It has been commonly used as a Chinese folk medicine for the treatment of rheu-matic arthritis, sciatica, hypertension and hemiplegia. Its main active ingredients are alkaloids. Corydalis Decumbentis Rhizoma extract, obtained through extraction from rhizome of Corydalis decumbens by 1% hydrochloric acid and separation by cation exchange resin, is the total alkaloids extract of Corydalis Decumbentis Rhizoma. Since the Corydalis Decumbentis Rhizoma preparations such as eye drops, injection and tablets are direcrly prepared by Corydalis Decumbentis Rhizoma extract, it is of great importantance to control the quality of Corydalis Decumbentis Rhizoma extract to assure the quality of its preparations.Current quality standards of Corydalis Decumbentis Rhizoma extract is listed after Corydalis Decumbentis Rhizoma eye drops( Committee of National Pharmacopoeia, 2010). Its testing programmes are characters, chemical identification for alkaloids, determination of protopine, moisture residue, ignition heavy metals residue and As salt residue determination. This quality standard lacks specific identification item. Meanwhile, it lacks item to control the resin remnant because of the use of cation exchange resin. Moreover, content determination item is the determination of protopine, it could not reveal the overall quality of Corydalis Decumbentis Rhizoma extract.On the basis of current quality standards, we increased the TLC identification with protopine and standard Corydalis Decumbentis Rhizoma extract. TLC spots were clear and well-separated. We also develop methods to determine the phenol, formaldehyde and salicylic acid to check the resin remnant from cation exchange resin using in the separation procedure, and make revelant method validations. Moreover, since the multiple ingredients in Chinese medicine as well as its preparations are complex, fingerprint technique, which considered as a useful method emphasizes on the integral characterization and can give an overall view of all components in Chinese medicine successfully, was used and seven main chromatographic peaks in fingerprint of Corydalis Decumbentis Rhizoma extract was identified as peaks for hydrohydrastinine, bulbocapnine, bicuculline, protopine, tetrahydropalmatine, jatrorrhizine and palmatine through comparing with the standard substances. Since Corydalis Decumbentis Rhizoma extract have several active ingredients, we developed a HPLC method to simultaneous determination of three active ingredients include protopine, tetrahydropalmatine and palmatine in Corydalis Decumbentis Rhizoma extract. The results of method validations indicated that methods mentioned above are specific and reliable with good reproducibility, and can be used for the quality control of Corydalis Decumbentis Rhizoma extract.