本文選題：復方中藥 + 凍干粉　； 參考：《黑龍江八一農(nóng)墾大學》2015年碩士論文

【摘要】：為了將一種傳統(tǒng)復方中藥制備成凍干粉粉針劑，并對其進行質(zhì)量研究及穩(wěn)定性考察。本試驗首先采用水醇法對中藥提取液進行除雜；并采用正交試驗方法，以藥液中主要成分（綠原酸、表告依春及苦參堿）的轉(zhuǎn)移率及鞣質(zhì)的去除情況為指標，對明膠法除鞣質(zhì)中的藥液濃縮比例、pH值和反應溫度三個因素進行考察；采用單因素試驗，對保護劑的種類和用量，藥品凍干濃度、藥液的pH值進行篩選，確定凍干配方；通過凍干機測定隔板溫度和樣品溫度，繪制降溫曲線確定樣品的共熔點；采用正交試驗方法，以凍干率為考察指標確定最佳凍干工藝參數(shù)；應用高效液相色譜法定量分析凍干粉中綠原酸、表告依春及苦參堿的含量來考察凍干粉的質(zhì)量；通過溶血性試驗、過敏性試驗、刺激性試驗考察凍干粉的安全性；通過影響因素試驗、加速試驗及長期試驗對凍干粉的穩(wěn)定性進行考察。 試驗結(jié)果：水醇法不能將藥液中的鞣質(zhì)完全去除，在藥液濃縮比例為1:3、藥液pH值為7、反應溫度為80℃時，藥液中有效物質(zhì)的轉(zhuǎn)移率較高，明膠法去除鞣質(zhì)效果良好；凍干配方為：凍干藥液濃度20%，，最佳保護劑為10%甘露醇，最佳pH值為6～7；樣品的最低共熔點為：-3℃～-8℃；最佳凍干工藝為：-50℃預凍5h、-20℃低溫升華干燥14h，30℃解析干燥10h；在此工藝條件下獲得的凍干粉成型性、外觀、復水性均良好，主成分含量均一穩(wěn)定，無溶血、過敏及刺激性反應；該凍干粉在高溫試驗、光照試驗、加速試驗以及長期試驗中穩(wěn)定性均良好。 綜上所述，該凍干粉配方合理，制備工藝可行，質(zhì)量安全可控，穩(wěn)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

本文編號：1863155