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

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.