Composite Injection Of Angelica Sinensis And Ligusticum Chuanxiong

A recipe, comprised of Angelica sinensis and Ligusticum chuanxiong, containing three active parts of volatile oil, organic acids, and alkaloid, is one of the important 'Duiyao' which were used to activate blood and remove blood stasis. It was proved to have a good function on treating ischemic cerebrovascular diseases at clinic. Based on isolating and purifying the active parts of the recipe, a composite injection of Angelica sinensis and Ligusticum chuanxiong was formulated. Stability research, pharmacological experiments, and preparation of fingerprint chromatograms of the formula were conducted in this paper.Quantitative analysis methods were established to analyze ferulic acid and Z-ligustilide in isolating and purifying processes. HPLC and TLC methods were set up to determine content of ferulic acid and Z-ligustilide simultaneously and assay them qualitatively.The active parts of the composite recipe were extracted by process of stream distillation and water-decocting, isolated by adsorption of D101 resin, purified by adsorption of polyamide, and then extacted with ether. Quality of the intermediates was qualified , and total content of ferulic acid and Z-ligustilide accounted for over 25 % in the intermediates.The influences of light, pH, temperature, HP β CD, cosolvents and stabilizers on stability of Z-ligustilide were investigated. It was found that a semi-aqueous vehicle which contained 0.5 g/ml herbal medicine, 0.8% tween-80, 20% 1,2-propanediol and 0.3%stablilizer S₁ was more suitable for the stability of ferulic acid and Z-ligustilide. In the semi-aqueous vehicle, remaining percentages of ferulic acid and Z-ligustilide were over 94.7% and 98% respectively after accelerating tests of 3 months under ambient temperature, and were both over 98% after long-term tests of 3 months at 4℃.Hemolysis, acute toxicity and irritation of the injection were examined and qualified. The function of the composite injection on treating ischemic cerebrovascular diseases and analgesic activity were evaluated by four model tests, including hypoxic method of mice that the heads of mice were cut down, ischemic cerebrovascular method of mice induced by NaNO₂, acetic acid-induced writhing method, and the mouse hot-plate method. The results of the tests showed that when a dose of over 2.5g/kg were given intraperitoneally (ip), respiration and surviving time of the mice was extended effectively, and when a dose of over 0.5g/kg were given, analgesic effects and pain thresholds in mice were increased significantly. The results suggested that the composite injection was effective in treating ischemic cerebrovascular diseases such as migraine and cerebral arteriosclerosis.Fingerprint chromatograms of Angelica sinensis, Ligusticum chuanxiong, and the composite injection were established to control their qualities. Results of tests for HPLC methods of the fingerprint chromatograms were up to grade. Total area ratio of all the uncommon peaks, relative retention time and relative area ratio of the common peaks all met the related requirements for fingerprint chromatograms of 10 batches of Angelica sinensis, Ligusticum chuanxiong, and the composite injection.