药用辅料羟丙基甲基纤维素的细胞毒性研究  

Cytotoxicity study of hydroxypropyl methylcellulose as a pharmaceutical excipient

作　　者：王国强[1] 曹静[2] 董平轩 张娟娟 张琦 WANG Guoqiang;CAO Jing;DONG Pingxuan;ZHANG Juanjuan;ZHANG Qi(Department of Clinical Laboratory,Dezhou Center for Disease Control and Prevention,Shandong,Dezhou 253016,China;Department of Quality Management,Dezhou Center for Disease Control and Prevention,Shandong,Dezhou 253016,China;School of Medicine and Nursing,Dezhou University,Shandong,Dezhou 253014,China)

机构地区：[1]山东省德州市疾病预防控制中心检验科,山东德州253016 [2]山东省德州市疾病预防控制中心质量管理科,山东德州253016 [3]德州学院医药与护理学院,山东德州253014

出　　处：《中国医药科学》2024年第13期45-48,共4页China Medicine And Pharmacy

基　　金：德州学院2019年度省级重点实验室(工程实验室/研究基地)开放基金项目(SD2019BP008)。

摘　　要：目的采用MTT比色法进行羟丙基甲基纤维素(HPMC)体外细胞毒性试验,以评价HPMC作为药用辅料的生物安全性。方法将L929细胞分为空白对照组(只加细胞培养液)、HPMC组(K4M、K100M两种规格,浓度分别为10.0、5.0、1.0、0.5、0.1 mg/ml)。置于培养箱中培养24、48 h,用MTT方法测定490 nm处的吸光度值,计算细胞毒性试验中细胞相对增殖率(RGR)。结果不同规格(K4M、K100M)、不同浓度(10.0、5.0、1.0、0.5、0.1 mg/ml)HPMC的平均细胞RGR>85%,属于无细胞毒性。结论研究结果证实HPMC对L929细胞无细胞毒性,这说明HPMC的细胞毒性达到国家标准对生物材料细胞毒性所限定的要求,为安全的药用辅料。Objective To conduct in vitro cytotoxicity tests of hydroxypropyl methylcellulose(HPMC)using MTT colorimetry to evaluate the biological safety of HPMC as a pharmaceutical excipient.Methods L929 cells were divided into a blank control group(with only cell culture medium added)and an HPMC group(with two specifications of K4M and K100M,with concentrations of 10.0,5.0,1.0,0.5,and 0.1 mg/ml,respectively).Cultured in an incubator for 24 and 48 h,the absorbance at 490 nm was measured by MTT method,and the relative growth rate(RGR)of cells in cytotoxicity test was calculated.Results The average RGR of HPMCs with different specifications(K4M,K100M)and concentrations(10.0,5.0,1.0,0.5,0.1 mg/ml)was>85%,indicating stepless cytotoxicity.Conclusion The study results confirm that HPMC has no cytotoxicity on L929 cells,indicating that the cytotoxicity of HPMC meets the requirements of national standards for the cytotoxicity of biomaterials,making it a safe pharmaceutical excipient.

关 键 词：羟丙基甲基纤维素 L929细胞 相对增殖率 MTT比色法 

分 类 号：R965[医药卫生—药理学]