Studies On Lyophilization Injection Of Corydalis Saxicola Bunting

The viral hepatitis (?) a group comprising of several different hepatitis virus infections, including hepatitis A,B,C,D and E. It's universal infection disease, and infected hundred millions of people every year. There were 2 million persons died of hepatitis. Hepatitis B was the worst disease because of worldwide distribution. There were approximately 300 million cases of hepatitis B over the world, and 120 million in china. According to some documents, 40 million persons are chronically infected with hepatitis virus in China. Meanwhile, Hepatitis B and C appeared to be the most significant causes of hepatocellular carcinoma, and could be one of deadly disease. Therefore, the prevention or remedy of hepatitis has become a important and hard responsibility of health services in China, especially for hepatitis B. At present, hepatitis can be treated with the drugs interferon, lamivudine, adefovir, ribavirin, and so on. But these drugs did not work for everyone. Traditional Chinese medicines have become potential treats for the virus hepatititis.The herbal drug Corydalis Saxicola Bunting (CSB) is the plant of poppy family, and has been used as a kind of Chinese traditional medicine applied to the prevention or remedy of hepatitis, hepatic cirrhosis and even hepatoma. But in injection of CSB on the market, the content of total alkaloids (TA) was low, about 30%. Our studies were based on finding the active compounds with high TA content by optimal purified technique and developing a kind Chinese medicine injection which had controllable quality and long-term stability.Firstly, we established simple, suitable assay methods for TA and dehydrocavidine(DHC). in CSB. Then using the content of TA and DHC as indexes, we compared purified technique by macroporous adsorption resin with others, such as cation resin and silica gel. At last, we optimized conditions of the macroporous resin technique for purifying TA. The parameters of the purified technique of TA were established, including the type of resin, time of adsorption, volume and concentration of sample solution, volume and the concentration of solvent of elution, flow velocity and regeneration of resin. The process study showed that HP₂MGL macroporous adsorption resin had the highest desorption ratio of TA and DHC, and acceptable adsorption ratio. The results showed that the optimal parameters of purification were the ratio of diameter to height of chromatographic column as 1/5-l/10, sample solution as 2.5BV 2.5mg/ml, flow velocity as 1BV/h,and 1.5BV water, 5.5BV 30% EtOH, 1%HC1 EtOH (non-aqueous) as the eluting solvent respectively, gathering the elution part of 30% EtOH. The content of TA and DHC was up to 53.9% and 7.098%, respectively, while before purification, these were just 29.2% and 2.775%.Based on the purified technique of TA, we prepared CSB extract. The result of accelerated test showed that CSB extract has a good stability.The formulation of lyophilization injection of CSB was optimized based on its shape and redissolving properties. As a result, the problems that the former injection was not stable and...