目的：探讨6种明胶胶囊药壳的致突变性，为研究药用明胶空心胶囊的安全性提供实验数据。方法以小鼠为受试对象，利用微核实验技术检测6种明胶胶囊药壳在4种不同剂量下对小鼠骨髓细胞微核率的影响，并制作肝脏病理切片观察小鼠肝组织病理学改变。结果在临床成人使用剂量及临床成人使用剂量100倍条件下，6种明胶胶囊药壳未引起小鼠微核率的明显升高（ P＞0.05），仅在高于临床成人使用剂量的200、400和800倍情况下，有3种明胶胶囊药壳对小鼠微核率的影响有统计学意义（P＜0.05，P＜0.01），但这6种明胶胶囊药壳对于小鼠肝脏均未造成有意义的病理改变。结论选用的6种明胶胶囊药壳在临床成人使用剂量及低剂量条件下没有诱导染色体损伤的遗传毒性，但在中、高剂量下，有3种明胶胶囊药壳具有致染色体损伤的效应，这种潜在的遗传毒理威胁应引起行业注意，选用优质的明胶胶囊药壳是关键。%Objective To study the mutagenic effect of six medicinal gelatin capsule shells, and to provide ex-perimental data on the safety of gelatin empty capsules.Methods The mice were given with four different doses of six gelatin capsule shells.The micronucleus rate of mouse bone marrow cells was detected using micronuclear test, and the liver pathological changes were subsequently observed by optical microscope.Results No significant increase in the mi-cronucleus rates was observed in mice with 6 medicinal gelatin capsule shells at the adult′s doses or 100 times of the adult′s doses (P>0.05);only at 200, 400 and 800 times the adult′s dose of 3 gelatin capsule shells there were significant im-pacts on the micronucleus rate ( P<0.05, P<0.01) .However, there was no significant change in the liver pathological observation by all the 6 medicinal gelatin capsule shells.Conclusion These six gelatin capsule shells do not induce genotoxic chromosomal damage at the adult′s doses or lower doses, however, it should be paid attention that three kinds of the six gelatin capsule shells had the potential to cause chromosomes breaking at the medium or high doses.Thus, it′s im-portant to choose quality medicine capsule shell for industry.
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