中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
8期
865-869
,共5页
右旋雷贝拉唑钠%CHL%染色体畸变
右鏇雷貝拉唑鈉%CHL%染色體畸變
우선뢰패랍서납%CHL%염색체기변
rabeprazole sodium dextral%CHL%chromosome aberration
目的：通过右旋雷贝拉唑钠对中国仓鼠肺成纤细胞（CHL）染色体畸变试验的研究，预测其是否具有遗传毒性。方法：采用MTT法检测右旋雷贝拉唑钠对CHL的细胞毒性作用，计算药物作用24 h和48 h的半数细胞生长抑制浓度，确定右旋雷贝拉唑钠染色体畸变试验的作用剂量。非代谢活化组和代谢活化组分别加入新鲜配制含右旋雷贝拉唑钠的细胞培养液（包括低、中、高剂量组）5 mL、4.5 mL，代谢活化组再加0.5 mL S9混合液，使24 h组右旋雷贝拉唑钠低、中、高剂量组药物终浓度分别为2、10、50μg·mL-1，48 h组低、中、高剂量组药物终浓度分别为1、5、25μg·mL-1。同时，试验设溶媒对照组和阳性对照组，甲醇-冰醋酸液固定、离心，取沉淀物混匀常规制片，姬姆萨染色。油镜下观察染色体结构畸变种类、频率。每例样本镜检200个中期相细胞，记录染色体数目及形态的变化。结果：右旋雷贝拉唑钠对CHL细胞毒性试验结果显示，24 h时IC50为48.49μg·mL-1，48 h时IC50为21.09μg·mL-1。右旋雷贝拉唑钠对CHL细胞染色体畸变作用的研究结果显示，右旋雷贝拉唑钠低、中、高剂量组分别作用细胞24 h和48 h，在加入S9混合液和未加S9混合液条件下所诱发的染色体畸变数均低于或等于5%，其畸变率与溶媒对照组相比均无显著性差异（P＞0.05）。结论：在本试验条件下，右旋雷贝拉唑钠染色体畸变试验结果为阴性。
目的：通過右鏇雷貝拉唑鈉對中國倉鼠肺成纖細胞（CHL）染色體畸變試驗的研究，預測其是否具有遺傳毒性。方法：採用MTT法檢測右鏇雷貝拉唑鈉對CHL的細胞毒性作用，計算藥物作用24 h和48 h的半數細胞生長抑製濃度，確定右鏇雷貝拉唑鈉染色體畸變試驗的作用劑量。非代謝活化組和代謝活化組分彆加入新鮮配製含右鏇雷貝拉唑鈉的細胞培養液（包括低、中、高劑量組）5 mL、4.5 mL，代謝活化組再加0.5 mL S9混閤液，使24 h組右鏇雷貝拉唑鈉低、中、高劑量組藥物終濃度分彆為2、10、50μg·mL-1，48 h組低、中、高劑量組藥物終濃度分彆為1、5、25μg·mL-1。同時，試驗設溶媒對照組和暘性對照組，甲醇-冰醋痠液固定、離心，取沉澱物混勻常規製片，姬姆薩染色。油鏡下觀察染色體結構畸變種類、頻率。每例樣本鏡檢200箇中期相細胞，記錄染色體數目及形態的變化。結果：右鏇雷貝拉唑鈉對CHL細胞毒性試驗結果顯示，24 h時IC50為48.49μg·mL-1，48 h時IC50為21.09μg·mL-1。右鏇雷貝拉唑鈉對CHL細胞染色體畸變作用的研究結果顯示，右鏇雷貝拉唑鈉低、中、高劑量組分彆作用細胞24 h和48 h，在加入S9混閤液和未加S9混閤液條件下所誘髮的染色體畸變數均低于或等于5%，其畸變率與溶媒對照組相比均無顯著性差異（P＞0.05）。結論：在本試驗條件下，右鏇雷貝拉唑鈉染色體畸變試驗結果為陰性。
목적：통과우선뢰패랍서납대중국창서폐성섬세포（CHL）염색체기변시험적연구，예측기시부구유유전독성。방법：채용MTT법검측우선뢰패랍서납대CHL적세포독성작용，계산약물작용24 h화48 h적반수세포생장억제농도，학정우선뢰패랍서납염색체기변시험적작용제량。비대사활화조화대사활화조분별가입신선배제함우선뢰패랍서납적세포배양액（포괄저、중、고제량조）5 mL、4.5 mL，대사활화조재가0.5 mL S9혼합액，사24 h조우선뢰패랍서납저、중、고제량조약물종농도분별위2、10、50μg·mL-1，48 h조저、중、고제량조약물종농도분별위1、5、25μg·mL-1。동시，시험설용매대조조화양성대조조，갑순-빙작산액고정、리심，취침정물혼균상규제편，희모살염색。유경하관찰염색체결구기변충류、빈솔。매례양본경검200개중기상세포，기록염색체수목급형태적변화。결과：우선뢰패랍서납대CHL세포독성시험결과현시，24 h시IC50위48.49μg·mL-1，48 h시IC50위21.09μg·mL-1。우선뢰패랍서납대CHL세포염색체기변작용적연구결과현시，우선뢰패랍서납저、중、고제량조분별작용세포24 h화48 h，재가입S9혼합액화미가S9혼합액조건하소유발적염색체기변수균저우혹등우5%，기기변솔여용매대조조상비균무현저성차이（P＞0.05）。결론：재본시험조건하，우선뢰패랍서납염색체기변시험결과위음성。
Objective:To evaluate the effects of dextral rabeprazole sodium ray Bella on chromosome aberration of China hamster lung ifbroblast cells (CHL), so as to predict whether it has genetic toxicity.Methods: The cytotoxicity dextral rabeprazole sodium on CHL cells was determined by MTT method, and half cell grouth inhibitory concerntration after 24-hour and 48-hour drug action was calculated. The effective dosage of dextral rabeprazole sodium on chromosome aberration was then determined. Freshly prepared dextral rabeprazole sodium cell culture medium (including low, middle, high dose group) was added to non-metabolic activation group (5 mL) as well as metabolic activation group (4.5 mL), and 0.5 mL S9 solution was then added to the metabolic activation group. For the 24 h groups, the concentration of H-ray Bella of cefmetazole sodium in low, medium, and high subgroups were 2, 10, 50 μg·mL-1. For the 48 h groups, the concentration of H - ray Bella of cefmetazole sodium in low, medium, and high subgroups were 1, 5, 25 μg·mL-1. At the same time, the vehicle control group and positive control group were also included for the study. The cells of different groups were ifxed in methanol-glacial acetic acid liquid, and Giemsa staining was performed. The chromosome structure aberration types and frequency were observed under oil microscope. 200 metaphase cells of each sample were selected under microscopy, and changes in chromosome number and morphological were recorded.Results:Our results showed that the IC50 of 24 h was 48.49 μg·mL-1, and 21.09 μg·mL-1 for 48 h. The cell chromosome aberration was less than or egualled to 5% of all the groups. No significant difference was observed among test groups and the control group (P>0.05).Conclusion:The chromosome aberration effects of Rabeprazole Sodium Dextral were negative under the condition of this experiment.
