| Yinqiaolanqin liquid was made from many kinds of Chinese medicinal materials,such as honeysuckle（family Caprifoliaceae）, forsythia（family Forsythia）, radix isatidis（family Cruciferous）, scutellaria （family Scutellaria L.） and commelina communis（family Commelina communis L.）. It has the effect of anti-inflammatory, analgesicand antipyretic. The paper focused on the study of quality standard and toxicologyresearch of Yinqiaolanqin liquid, which makes basis for experimental and theoreticalin clinical applications.1. To establish identification methods of Fructus Flos Lonicerae, Forsythiae, RadixScutellariae in Yinqiaolanqin liquid by TLC. Result showed Yinqiaolanqin liquid,Control medicinal materials and standard substance in the corresponding position inthe chromatogram displayed the same color spots, the corresponding blank-controlhad no pots. Qualitative and quantitative method was simple, accurate, reproducibleand good sense can be used as Yinqiaolanqin liquid quality control standards.2. To establish a HPLC method for the quantitative determination of chlorogenicacid, baicalin and forsythin in Yinqiaolanqin liquid. All separations were performedon a Kromasil ODS-1 C18colume（250mm×4.6mm，5μm）. HPLC experimentswere run at the temperature30°C. Injection volume was10μL.Flow rate was1.0mL/min. The mobile phase of chlorogenic acid, baicalin and forsythin were methanol-pH3.0phosphoric acid solution （20:80）, methanol-pH3.0phosphoric acid solution （50:50） and acetonitrile-water （25:75） respectively. The detection wavelengths of thosewere324nm,274nm and324nm respectively. The retention time of chlorogenic acid,baicalin and forsythin was14.628min,9.447min and13.648min. The method issimple, accurate, sensitive and can be used for quality control of multicomponent inYinqiaolanqin liquid.3. To study the stability of Yinqiaolanqin liquid with the characteristics, clarity, pHvalue, relative density and active ingredient contents as indices. The stability ofYinqiaolanqin liquid under constant temperature and humidity was investigated underaccelerated （40±2℃, RH75±5%,6months） conditions. Sampling once a month during the experiment, determination of chlorogenic acid, baicalin and forsythin inYinqiaolanqin liquid by HPLC, inspection characteristics, clarity, related substancesand other changes. Along with the prolong of time, content of chlorogenic acid,baicalin and forsythin in Yinqiaolanqin liquid was no significant changes in thefluctuations, its content was still be kept within bounds. Other parameters had nosignificant changes in the examination, no insoluble particle was appeared, in linewith the provisions of pharmaceutical quality standards. The Yinqiaolanqin liquidcould meet the needs of clinical medicine with quality control easy and excellentstability.4. The Yinqiaolanqin liquid has the effect of anti-inflammatory, analgesic andantipyretic. No toxicity investigations have been carried out on this liquid. This studythus aimed to characterize its acute and subacute toxicity of Yinqiaolanqin liquid afteradministration in mice and rats. The acute toxicity of Yinqiaolanqin liquid wasinvestigated by intramuscular injection to mice at doses ranging from1.00to18.90g·kg-1. General behavior, adverse effects and mortality were determined for upto7days post treatment. In the subacute study, Yinqiaolanqin liquid was given byintramuscular liquid as a single administration to wistar rats at doses of0.5,2.5and12.5g·kg-1for16days. Animal body weights were observed throughout theexperimental period while hematological and biochemical indexes of blood, as wellas heart, liver, spleen, lung, kidney and brain tissues histology were evaluated at theend of the experiment. In the acute toxicity study in mice, none of the doses usedinduced mortality or significant behavior changes. In the subacute toxicity study inrats, the results showed that intramuscular injection of Yinqiaolanqin liquid at dailydose of up to12.5g·kg-1had no adverse effect on hematological and clinicalbiochemical indexes and induced no significant changes in body and organs weights.Histological studies showed that the treatments did not induce any pathologicalchanges in the liver, kidney, heart, spleen and lung of the animals. These resultsdemonstrated that there was a wide margin of safety for the therapeutic application ofYinqiaolanqin liquid. There was no acute toxicity in mice following intramuscularinjection at doses ranging from1.00to18.90g·kg-1. And there was no treatment-related subacute toxicity in rats following16-day intramuscularadministration of0.5,2.5and12.5g·kg-1Yinqiaolanqin liquid. |
PDF Full Text Request