Study On Quality Standard Of Garlic Effective Fraction

Object: Based on the Chinese Pharmacopeia(2005) ,we have formulated the quality evaluation methods of garlic effective fractions in accordance with"Guiding principle in normalization procedure of establishing chemicals quality standard".According to"Specification about fingerprint of injection of traditional chinese medicines(Tentaive standard)", we have established fingerprints and technical parameter of garlic effective fractions. Methods: 1 Identification: Identification condition on TLC: The thin layer plates of silica gel were used and Alliin was made as reference substance. Developing solvent systerm was made up of n-butanol, glacial acetic acid and water(4∶1∶1), spray reagent was 0.2% ninhydrin. UV condition: undertaking spectral screen and taking water as solvents. 2 Inspection: Determining items of sample: including chlorides, sulfate, loss on drying, heavy metal and arsenic salt. 3 Assaying: We determined the content of the alliin of sample using the method of HPLC and UV. In experiment of HPLC, the chromatogram conditions as follow: YMC-Pack ODS-A(5μm,250×4.6mm) as chromatogram colum, mobile phase was 0.02% trifluoroacetic acid solution, flow rate was 0.5 ml·min-1, column temperature was 40℃and detective wavelength was 214nm; In experiment of UV, we determined alliin content in sample water solvents in 214nm wavelength . 4 Fingerprint establishment: Using Alliin as reference substance, we adopted the method of HPLC-DAD/ELSD and used the same chromatogram condition as HPLC; the ELSD detector parameters: atomization temperature was 40℃, pressure of eluant gas was 3.5bar; we have analyzed fingerprints of 10 batches of samples and evaluated these chromatograms by"Similarity Evaluation system for Chromatographic Fingerprint of traditional chinese medicine (Version 2004 A)". Results: 10 batches of samples have the same number and colour spot at the the same Rf on the thin layer plates. We found the absorption maximum wavelength was 214±1nm from the UV spectrum of samples and reference substance. The limits of chlorides ,sulfate , loss on drying, heavy metal and arsenic salt were all in line with Chinese Pharmacopeia; In the assaying, the precision, reproducibility and recovery were all accord with requirements.Based on"Similarity Evaluation system for Chromatographic Fingerprint of traditional chinese medicine (Version 2004 A)", we analyzed the fingerprint of 10 batches of samples. The similarity of samples was all above 0.990. These results were accorded with the principle of fingerprint. Conclusion: The results indicated that we have achieved the expression of overall characteristic of garlic effective fraction through studying the quality standards and fingerprint ,namely the combination of qualitative and quantitative ,and we also provided a reliable and important basis of quality evaluation of garlic effective fraction.