| Qizhixiaoliu Capsule is a preparation of Traditional Chinese Medicine (TCM) obtained from Radix Astragali, Hirudo, Ramulus Cinnamomi and Spica Prunellae, which has the functions of invigorating qi and promoting the blood circulation, eliminating dampness through diuresis, diminishing swelling and soften indurated mass. In clinic, it was used to postoperative recovery. The process, standard of quality and stability of the medicine were studied with the theory of TCM, pharmacology and the demand of clinic.On the basis of the function of treatment of the prescription and the characters of the effective component of the herbs, the optimal preparation process was designed with the orthogonal experiment as well as quite a few assessing·norms to evaluate them comprehensively. The optimal extract conditions were that Hirudo was extracted 3 times with 6-fold volume of 80% ethanol,1 hour each time,and 60℃temperature. Astragali, Ramulus Cinnamomi and Spica Prunellae were extracted 2 times, with 8-fold volume of water,1 hour each time. The purifying technology was that it is condensed all the extracted solutions to 1.2 g/ml and then added 10%(ml/ml) 5% 101 fruit juice clarifying agent, filtered, the solutions was condensed to the density about 1.1, dried by spray, added some adjuvant and wet granulation, then dryed, sprayed into volatile oil and put it into capsules.In the study of the quality standard, the identify methods of Radix Astragali, Hirudo, Ramulus Cinnamomi and Spica Prunellae with'Thin Layer Chromatograph were established. Meanwhile, the contents of Raidx Astragali was determined by HPLC-ELSD which was taken as an inherent index to estimate the products and accomplished the systematic methodology.Preliminary stability research had kept on 3 months, the samples under the long experiment at room temperature were measured according to the quality stamdard, the results indicate that Qizhixiaoliu Capsule was stable and the packing was suitable.The results indicate that the preparation process is reasonable and practical, the quality of the medicine is controllable and stable. |