The Research Of Rhizoma Gastrodiae Liguspyragine Hydrochloride For Injection

In this work, Rhizoma Gastrodiae was identified by TLC; The method was established for determining the content of gastrodine in Rhizoma Gastrodiae by HPLC, the linear range of gastrodine was 16¹60mg ? L^-1(r=0.9998); the mean recovery was 99.83% (RSD= 1.40%,n=9), The content of gastrodine in four samples from different regions was determined. The method for assaying Liguspyragine Hydrochloride was also built up by HPLC, the linear range of Liguspyragine Hydrochloride was 4⁴0mg ? L^-1(r=0.9997). The accuracy, reliability and repeatability of two methods were excellent.Orthogonal experiment design and single factor tests were used in optimizing the extraction and purification technology of Rhizoma Gastrodiae by measuring transition probability. The main process: the granulates of Rhizoma Gastrodiae were soaked by water for 12 hours, then reflux-extracted by 10 multiples of water 3 times (2 hours per time). The extraction concentrated was deposited two times by alcohol (60% alcohol in first time, 80% alcohol in second time and adjusted pH value at 8.3 to 8.5). The result indicated that transference rate of Rhizoma Gastrodiae could arrive at 84.99% and impurities could be cleaned out efficiently in this process.The prescription of freeze-dry preparation was optimized by the criterion of appearance, water content and re-solubility. Mannitol (150mg/ampule) was used as filler. The quality of Rhizoma Gastrodiae Liguspyragine Hydrochloride (RGLH) for injection was studied, and the quality standard was built up. The result showed that the products agreed with the quality requirements of Chinese herbal injection. The quality could be controlled by the standard established considerably, and the clinical safety could be ensured.HPLC fingerprints of Rhizoma Gastrodiae herbals and RGLH for injection was established , average vector method was used to built up standard fingerprints respectively , and similarity was calculated by using the cosine of included angle. The fingerprints established agreed with "Technical Requirement of Fingerprint Research of Chinese Herbal Injection". Compared with the standard fingerprints respectively, the similarities of the fingerprints of crude and preparation were 0.8662 to 0.9082 and 0.9981 to 0.9998. The result showed that the quality of this drug was stable and the distinction of different batch was minute; the manufacturing technology was also stable and the repeatability of different batches was good.The special safety tests indicated that, according to the optimized extraction and purification technology, the products were safe. Pharmacodynamic tests showed that the products could enhance the endurable ability against oxygen deficiency of mice, relieved the encephaledema of rats caused by acute blood deficit in brain, decreased the brain index and prolonged the survival time of rats which were experimental blood deficiency in brain, increased prothrombin time (PT), decreased specific viscosity of whole blood, plasma and fibrin. It also could antagonize platelet aggregation and thrombus formation in vivo of rabbits, increased the brain blood flow of dogs.