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目的:确立复方楂金颗粒浸提中试工艺及质量指标,明确复方楂金颗粒的急性毒性,对其进行安全性评价,以指导其临床用药的安全性。方法:对提取、浓缩及干燥中试工艺的关键技术参数进行考核,以浸膏得率和绿原酸含量为考核指标;采用复方楂金颗粒中试流浸膏,以最大给药量试验进行急性毒性试验,观察小鼠给药后及14 d内反应情况,记录外观、活动、饮食、排泄、体质量及死亡等情况,14 d后解剖小鼠观察其重要脏器的变化。结果:复方楂金颗粒浸膏得率为11.06%,绿原酸含量为0.0170%。14 d观察期内无小鼠死亡,体质量增长正常,与空白对照组比较无显著差异(P>0.05)。重要脏器大体解剖及病理切片均未见异常改变。未测得LD50,其最大给药量为280.0 g/kg,相当于人用临床日剂量的157倍,未出现异常的毒性反应。结论:复方楂金颗粒中试工艺可靠,设备及其性能稳定,在拟订临床用药剂量的150倍以上是安全的。
OBJECTIVE: To establish the pilot process and quality index of compound hawthorn gold granules extraction, to clarify the acute toxicity of compound hawthorn gold granules and to evaluate the safety of the compound in order to guide the safety of its clinical use. Methods: The key technical parameters of the extraction, concentration and drying pilot process were evaluated, and the extract yield and chlorogenic acid content were taken as the assessment indexes. The compound DF was used to test the maximum dosage The acute toxicity test was conducted to observe the response of mice after administration and within 14 days. The appearance, activity, diet, excretion, body weight and death were recorded. The changes of vital organs were observed after 14 days. Results: The extraction rate of compound hawthorn gold granules was 11.06% and the content of chlorogenic acid was 0.0170%. No mice died during the 14 d observation period, body weight growth was normal, no significant difference compared with the blank control group (P> 0.05). The main organs of gross anatomy and pathological sections were no abnormal changes. Not measured LD50, the maximum dose of 280.0 g / kg, equivalent to 157 times the clinical daily dose, no abnormal toxicity. CONCLUSION: The compound hawthorn gold pellets have reliable pilot process, stable equipment and stable performance, and it is safe to formulate more than 150 times of clinical dosage.