Study On The Quality Criterion Of Water-Soluble Constituents Of Salvia Miltiorrhiza In Xinjikang Injection

With the development of TCM modernization, the quality criterion qualified for the international request will go ahead from study to practice. Our SDA took Chinese injection as a model at first, requesting explicitly by the end of 2004 that Chinese injection must provide fingerprint chromatography.According to the request strictly, the fingerprints of every ten batches of Xinjikang injection, Radix Salvia miltiorrhiza and the substances were set up by HPLC of gradation technology. It proved this method was easy, convenient and could be repeated simply. The studies are useful for the quality control of Radix Salvia miltiorrihiza and its injection. Furthermore, The similarity of the fingerprint chromatography about Xinjikang injection, Radix Salvia miltiorrhiza and the substance of Xinjikang injection are all above 99%. It proved the fingerprints were stable and practical.On the basic of this, salvianolic acidB, Rosmarinic acid, protocatechualdehyde and Danshensu having the highest amounts in Radix Salvia miltiorrhiza were used as index contents, the chromatography peaks of Xinjikang injection, the substance of Xinjikang injection and Radix Salvia miltiorrhizairrhiza were identified and analyzed quantitatively, their amounts added up to 56.88%,which coincide with the request of active components in the Chinese injection and is a stable basic for the next study.