Study On The HPLC Fingerprint Chromatograms Of Quganre Injection And Rhizoma Arundinis Donacis

Quganre Injection is a kind of Chinese traditional medicinal injection, which is extracted from Rhizoma Arundinis Donacis, Artemisia nanua L., Bupleurum marginatum Wall Herbs and plaster. It has been used in treating fever caused by the upper respiratory tract infection, and has good effects. It is reported that there are N,N-Dimethyltryptamine, Bufotenine and some other indole alkaloids in Artemisia nanua L., which have effects to lower the pressure, relieve the convulsion caused by histamine, 5- hydroxytryptamine and acetylcholine, and can be used to treat the oedema. The study on the alkaloids in Rhizoma Arundinis Donacis has not be seen in the domestic report, and the foreign literatures just relate to the separation and identification of the active components in it Up to the present, the quality standard of Quganre injection only includes the identification of Rhizoma Arundinis Donacis and Artemisia by TLC, and the assay of total alkaloids in Rhizoma Arundinis Donacis by the gravimetric analysis. There is few reports about the chemical components of Quganre injection and its quality control methods. In order to assure the quality in Quganre Injection, we studied the fingerprint chromatograms of Quganre injection and the medicinal materials involved.Quganre injection contains the distillation of the Artemisia annua and Bupleurum marginatum Wall Herbs, the decoction of Rhizoma Arundinis Donacis and plaster, and someBenzvl alcohol and Tween 80. According to the preparation processes, the chemical components in Quganre injection can be divided into two parts, the volatile part and the non-volatile part. The paper studied on the fingerprint chromatograms of the non-volatile part .In order to set up the standard fingerprint chromatograms of Quganre injection ,we separated the alkaloid I , and used it as the reference subatance. We also separated another new alkaloid, whose structure is waited to be confirmed. Both of them are the main components of Quganre injection.We designed two methods to determine different kinds of components. Firstly, we divided the sample into two parts by liquid-liquid extraction, the lipophilic part (include alkaloids) and the water-soluble part. The sample was adjusted to alkaline by Ammonia solution and was extracted with chloroform. Lipophilic solution was prepared with the chloroform phase. Water-soluble solution was prepared with the water phase. Secondly, determine the lipophilic solution with IP-HPLC. A Luna 5u C18 (2) (250 × 4.6mm) was used . Mobile phase consisted of Acetonitrile-20mmol/LKH₂PO₄ (adjust pH 3.0 with H₃PO₄)(48:52) , with 5mmol/L SDS; detecting wavelength was set at 280nm.Under this condition, 18 peaks can be got from the lipophilic solution, 12 peaks of them were confirmed to be basic components. On the other hand, the water-soluble components were determined with RP-HPLC. A Luna 5u C18 (2) (250 × 4.6mm) was used. Mobile phase was methanol-water (5:95); detecting wavelength was set at 254nm. Under this condition, 14 peaks can be got from the water-soluble solution, which were separated well from each other.After decocted and dealt with alcohol, Rhizoma Arundinis Donacis was also divided into the lipophilic part and the water-soluble part by liquid-liquid extraction, and were separated by HPLC. The conditions conform to the injection. Under the condition, both sorts of components are separated well.We examined the robustness, precision and the solution's stability of the lipophilic part and the water-soluble part in injection. So do with Rhizoma Arundinis Donacis. All of themconformed to the requirements.We selected 10 batches of injections and Rhizoma Arundinis Donacis to set up the standard fingerprint chromatogram modes of the lipophilic part and the water-soluble part in injection and Rhizoma Arundinis Donacis. Then, we determined the fingerprint chromatograms of 5 batches of injections and Rhizoma Arundinis Donacis respectively, and calculate the cosine of inclination with the standard mode, evaluate their comparability.Based on the work above, we set up the fingerprint chromatogram quality standards of the lipophilic part and the water-soluble part in the injection and Rhizoma Arundinis Donacis, which offer guarantee for the complete control of Quganre injection and Rhizoma Arundinis Donacis, and gave a clue to study the effect mechanism of Quganre injection. It is helpful for the establishment of Chinese traditional medicine's fingerprint chromatogram, which contain alkaline and non- alkaline components.