| 第 52 卷第 2 期 |  | Vol. 52 No. 2 | | 2022 年 4 月 | Apr 2022 |
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所屬欄目：分析與測試
動(dòng)態(tài)濁度法測定乳酸鈉林格注射液中細菌內毒素含量的研究 |
| 姜艷玲1，李 嬋2，趙 敏1
（1.西安萬(wàn)隆制藥股份有限公司，陜西 楊凌 712100；2.陜西省藥品和疫苗檢查中心，陜西 西安 710065） |
| 摘 要：采用細菌內毒素檢測儀，基于動(dòng)態(tài)濁度法測定了乳酸鈉林格注射液在不同生產(chǎn)階段中細菌內毒素的含量。細菌內毒素含量在0.003 906~1.000 0 EU/mL范圍，∣r∣=0.991 0（≥0.980 0），標準曲線(xiàn)回歸方程為：y=-0.229 8x+2.894 9，線(xiàn)性回歸關(guān)系良好，標準曲線(xiàn)可靠；乳酸鈉林格注射液的濃配、稀配、灌裝及成品2倍稀釋時(shí)，回收率99%~135%，符合50%~200%的要求，實(shí)驗無(wú)干擾作用，3批不同階段樣品結果均小于0.50 EU/mL。該方法無(wú)干擾、檢測靈敏度及準確度高、數據可靠，適用于乳酸鈉林格注射液生產(chǎn)過(guò)程中細菌內毒素含量的測定。 |
| 關(guān)鍵詞：動(dòng)態(tài)濁度法；乳酸鈉林格注射液；細菌內毒素 |
| 中圖分類(lèi)號：TQ423 文獻標識碼：A 文章編號：1009-9212（2022）02-0077-04 |
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| Dynamic Turbidimetric Determination of Bacterial Endotoxin in Sodium Lactate Ringer Injection |
| JIANG Yan-ling1, LI Chan2, ZHAO Min1
(1. Xi'an WanLong Pharmaceutical Co.,Ltd., Yangling 712100, China; 2. Shaanxi Center for Drug and Vaccine inspection, Xi'an 710065, China) |
| Abstract：The dynamic turbidimetric method was used to determine the bacterial endotoxin content of Sodium Lactate Ringer Injection in different production stages using bacterial endotoxin detector. The results showed that with a bacterial endotoxin content range of 0.003 906~1.000 0 EU/mL， ∣r∣=0.991 0(≥0.980 0), The standard curve regression equation is as following: y=-0.229 8x+2.894 9. The linear regression relationship was good, and the standard curve was reliable. In the stage of thick blending, thin blending, filling and finished for Sodium Lactate Ringer Injection at 2 times dilution, the recovery rates were 99%~135%, which meet the requirements of 50%~200%, the test had no interference effect, and the test results of 3 batches in the different stages of samples were less than 0.50 EU/mL. This established method has no interference with high detection sensitivity and accuracy, and the data were reliable. This method is suitable for the determination of bacterial endotoxin content in Sodium Lactate Ringer Injection. |
| Key words：dynamic turbidity method; Sodium Lactate Ringer Injection; bacterial endotoxin |
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作者簡(jiǎn)介：姜艷玲（1978—），女，陜西西安人，執業(yè)藥師，研究方向：藥物分析和藥品質(zhì)量管理工作。
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收稿日期：2021-10-20
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