The Research Of Da Rhizoma Chuanxiong Hydrochloride For Injection

In this study, Rhizoma Chuanxiong and Rhizoma Gastrodiae were identified with simple TLC methods. Compared with controls and herbal controls, the sample had the pot of same color in the corresponding position. Negative sample hadn't any interference. The methods of HPLC were built up to determine the content of two main ingredients. The two methods were accurate, reliable and repeatable.Orthogonal experiment design and single factor tests were used in optimizing the extraction and purification technology of Rhizoma Chuanxiong and Rhizoma Gastrodiae by measuring transition probability. The main process: Rhizoma Chuanxiong and Rhizoma Gastrodiae were both reflux-extracted with water; Rhizoma Chuanxiong was purified with the methods of ethanol deposition, 20% calcicium hydroxide - sulfuric acid - ethanol and water deposition; Rhizoma Gastrodiae was purified with the methods of basic - ethanol deposition and water deposition. The result indicated that transference rate of ferulic acid could arrive at 77.01% and Rhizoma Gastrodiae could arrive at 84.85% , the impurities such as protein, resin, oxalate and Potassium were all removed.The prescription of freeze-dry preparation was optimized by the appearance, water content and re-solubility. Mannitol (160mg/ampule) was used as filler. The quality of Da Rhizoma Chuanxiong Hydrochloride (DRCH) 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, and the clinical safety could be ensured. Preliminary stability test showed that the stability of this product is good.HPLC fingerprints of Rhizoma Chuanxiong herbals and DRCH for injection, Rhizoma Gastrodiae herbals and DRCH for injection were established , 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". In comparision with the...