一种传统复方中药冻干粉的研制

发布时间：2018-05-08 21:35

  本文选题：复方中药 + 冻干粉　； 参考：《黑龙江八一农垦大学》2015年硕士论文

【摘要】：为了将一种传统复方中药制备成冻干粉粉针剂，并对其进行质量研究及稳定性考察。本试验首先采用水醇法对中药提取液进行除杂；并采用正交试验方法，以药液中主要成分（绿原酸、表告依春及苦参碱）的转移率及鞣质的去除情况为指标，对明胶法除鞣质中的药液浓缩比例、pH值和反应温度三个因素进行考察；采用单因素试验，对保护剂的种类和用量，药品冻干浓度、药液的pH值进行筛选，确定冻干配方；通过冻干机测定隔板温度和样品温度，绘制降温曲线确定样品的共熔点；采用正交试验方法，以冻干率为考察指标确定最佳冻干工艺参数；应用高效液相色谱法定量分析冻干粉中绿原酸、表告依春及苦参碱的含量来考察冻干粉的质量；通过溶血性试验、过敏性试验、刺激性试验考察冻干粉的安全性；通过影响因素试验、加速试验及长期试验对冻干粉的稳定性进行考察。 试验结果：水醇法不能将药液中的鞣质完全去除，在药液浓缩比例为1:3、药液pH值为7、反应温度为80℃时，药液中有效物质的转移率较高，明胶法去除鞣质效果良好；冻干配方为：冻干药液浓度20%，，最佳保护剂为10%甘露醇，最佳pH值为6～7；样品的最低共熔点为：-3℃～-8℃；最佳冻干工艺为：-50℃预冻5h、-20℃低温升华干燥14h，30℃解析干燥10h；在此工艺条件下获得的冻干粉成型性、外观、复水性均良好，主成分含量均一稳定，无溶血、过敏及刺激性反应；该冻干粉在高温试验、光照试验、加速试验以及长期试验中稳定性均良好。 综上所述，该冻干粉配方合理，制备工艺可行，质量安全可控，稳定性良好。
[Abstract]:In order to prepare a kind of traditional Chinese medicine as lyophilized powder injection, the quality and stability of it were studied. In this experiment, the method of water and alcohol was used to remove impurities from the extract of traditional Chinese medicine, and the transfer rate of the main components (Lv Yuan acid, epiphacrine and matrine) and the removal of tannins were used as the indexes of orthogonal test. Three factors, pH value and reaction temperature of concentration ratio and reaction temperature in tannins by gelatin method were investigated, and the formula of freeze-drying was determined by single factor test, including the type and dosage of protective agent, the concentration of drug lyophilization and the pH value of drug solution. The common melting point of the sample was determined by drawing the cooling curve by measuring the temperature of the diaphragm and the temperature of the sample by the freeze-drying machine, and the optimum parameters of the freeze-drying process were determined by using the orthogonal test method and the freeze-drying rate as the inspection index. High performance liquid chromatography (HPLC) was used to quantitatively analyze the content of Lv Yuan acid and matrine in freeze-dried powder, and the safety of freeze-dried powder was investigated by hemolytic test, hypersensitivity test and irritation test. The stability of freeze-dried powder was investigated by factor test, accelerated test and long-term test. The results showed that water alcohol method could not completely remove tannins from the solution. When the concentration ratio of the solution was 1: 3, the pH value of the solution was 7, and the reaction temperature was 80 鈩

本文编号：1863155