|
Tanreqing Injection is one of the most popular traditional Chinese medicinal injections, and it is the second category novel drug in our country. Tanreqing Injection is used for the treatment of upper respiratory tract infection, bronchitis, hepatitis and so on, which is formed by five extracts from Radix Scullariae, Fructus Forsythiae, Flos Lonicerae, Cornu caprae hircus, and Fel Ursi. Therefore the quality of each composition is important for Tanreqing Injection. Now aiming to the quality control for the extract of Flos Lonicerae, its chemical substances and preparative craftwork had been studied. The main contents were summarized as the follows:a) The chemical compositions of the extract of Flos Lonicerae had been studied. By the preparative HPLC, six compounds were isolated from the extract and identified as neochlorogenic acid, caffeic acid, chlorogenic acid, 3,4-dicaffeoylquinic acid, 3,5-dicaffeoylquinic acid and 4,5-dicaffeoylquinic acid.b) An HPLC-UV quantitive method for the simultaneous analysis of six components in the extract of Flos Lonicerae had been built. And the method validation including the linearity, the inter- and intra-day precision, the repeatability, the stability, and the recovery test had been carried out. The linearities of six compounds in the extract were obtained with r > 0.999. The RSD of the precision and the recovery test were not more than 5%. And the RSD of the repeatability and the stability were less than 3%.c) The preparative process of the extract of Flos Lonicerae had been investigated. The parameters such as pH value had been found to affect the quality of this extract. The suitable pH values are 3.5-4.0 and 6.0-6.5 for acid-precipitation process and for neutral solution. The soluble efficiency was positive correlation with the volume of ethanol solution and the concentration of the ethanol in its solution. The volume of n-Butanol and extract times may affect the result of solvent partition.
|