CAJ | 학술논문

目的观察经皮反复给予玉红膏对大鼠肝、肾功能及心、脑、肝、肾、脾等主要脏器组织形态学的影响,为临床安全用药提供实验数据.方法 SPF级SD大鼠100只,体重200 g,雌雄各半.用抽签法随机分为基质对照组、1倍浓度玉红膏组(轻粉含量0.4％)、2倍浓度玉红膏组(轻粉含量0.8％)、4倍浓度玉红膏组(轻粉含量1.6％)和1.6％轻粉组,每组20只.制备大鼠皮肤破损模型,经破损皮肤涂抹不同浓度玉红膏,1次/d,连续28 d.分别于给药前、给药14、28 d和停药28 d测定各组大鼠血清丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、尿素氮(BUN)、肌酐(Cr)和N-乙酰-β-D氨基葡萄糖苷酶(NAG)水平;给药28 d和停药28 d时每组各处死10只大鼠,取心、脑、肝、肾、脾等脏器称重,计算脏器系数,并取肝、肾、脾组织观察形态学改变.结果不同浓度玉红膏组和1.6％轻粉组大鼠ALT、AST、BUN、Cr和NAG水平与同期基质对照组比较差异无统计学意义(均P＞0.05);停药28 d时,1.6％轻粉组大鼠血清Cr含量高于基质对照组(P＜0.05).给药28 d与停药28d时,2和4倍浓度玉红膏组、1.6％轻粉组大鼠的肾脏系数均明显高于基质对照组(均P＜0.05).各组大鼠心、脑、肝、脾脏器系数的差异均无统计学意义(均P＞0.05).给药28 d时各组大鼠肝、肾、脾组织均无明显形态学改变.结论经皮反复给予玉红膏未发现大鼠出现明显的器官毒性反应,高浓度的玉红膏可能导致大鼠发生可逆转的肾损伤.提示临床长期大量应用玉红膏应监测患者的肾功能.
목적 관찰경피반복급여옥홍고대대서간、신공능급심、뇌、간、신、비등주요장기조직형태학적영향,위림상안전용약제공실험수거.방법 SPF급SD대서100지,체중200 g,자웅각반.용추첨법수궤분위기질대조조、1배농도옥홍고조(경분함량0.4％)、2배농도옥홍고조(경분함량0.8％)、4배농도옥홍고조(경분함량1.6％)화1.6％경분조,매조20지.제비대서피부파손모형,경파손피부도말불동농도옥홍고,1차/d,련속28 d.분별우급약전、급약14、28 d화정약28 d측정각조대서혈청병안산전안매(ALT)、천동안산전안매(AST)、뇨소담(BUN)、기항(Cr)화N-을선-β-D안기포도당감매(NAG)수평;급약28 d화정약28 d시매조각처사10지대서,취심、뇌、간、신、비등장기칭중,계산장기계수,병취간、신、비조직관찰형태학개변.결과 불동농도옥홍고조화1.6％경분조대서ALT、AST、BUN、Cr화NAG수평여동기기질대조조비교차이무통계학의의(균P＞0.05);정약28 d시,1.6％경분조대서혈청Cr함량고우기질대조조(P＜0.05).급약28 d여정약28d시,2화4배농도옥홍고조、1.6％경분조대서적신장계수균명현고우기질대조조(균P＜0.05).각조대서심、뇌、간、비장기계수적차이균무통계학의의(균P＞0.05).급약28 d시각조대서간、신、비조직균무명현형태학개변.결론 경피반복급여옥홍고미발현대서출현명현적기관독성반응,고농도적옥홍고가능도치대서발생가역전적신손상.제시림상장기대량응용옥홍고응감측환자적신공능.
Objective To observe the effects of Yuhong Ointment on rat's liver and kidney functions and histomorphology of heart,brain,liver,kidney and spleen after transdermal administration repeatedly,in order to provide experimental evidences for safe use of Yuhong Ointment in clinical practice.Methods A total of 100 SPF SD rats of equal number of both genders,weighting 200 g,were divided into 5 groups:matrix control group,1 time concentration of Yuhong Ointment group (containing 0.4％ calomel),2 times concentration of Yuhong Ointment group (containing 0.8％ calomel),4 times concentration of Yuhong Ointment group (containing 1.6％ calomel) and calomel group (containing 1.6％ calomel) by drawn lots randomly,each group comprised 20 rats.The model of rat's skin injury was prepared.Yuhong Ointment in different concentrations were applied on the skin-impaired once daily for 28 days.The levels of alanine aminotransferase (ALT),aspartate aminotransferase (AST),blood urea nitrogen (BUN),creatinine (Cr) and N-acetyl beta-D glucosaminidase (NAG) of rats in different groups were measured before treatment,14 and 28 days after treatment,and 28 days after drug withdrawal,respectively.Ten rats in every group were sacrificed on 28 days after treatment and 28 days after drug withdrawal,respectively.The heart,brain,liver,kidney,and spleen of rats in different groups were taken and weighed up.The organ coefficients were calculated and the histomorphological changes of liver,kidney and spleen were examined.Results There were no statistically significant differences in levels of serum ALT、AST、BUN、Cr and NAG in rats among the different concentrations of Yuhong Ointment groups,1.6％ calomel group and matrix control group (all P ＞ 0.05).The level of serum Cr in rat of 1.6％ calomel group was significantly higher than that of matrix control group 28 days after drug withdrawal (P ＜ 0.05).The kidney coefficients of rats in 2 times and 4 times concentration of Yuhong Ointment group and 1.6％ calomel group were significantly higher than that in the matrix control group (P ＜ 0.05) on 28 days after treatment and 28 days after drug withdrawal.The differences of coefficients of heart,brain,liver,and spleen of rats in different groups were not statistically significant (all P ＞ 0.05).There were no obvious morphological changes in liver,kidney and spleen in different groups 28 days after treatment.Conclusions No obvious toxic reactions were observed in rats after transdermal administration of Yuhong Ointment repeatedly.The high concentrations of Yuhong Ointment maybe bring reversible kidney injury.The kidney function of patient who received large volume of Yuhong Ointment for long-term should be monitored.