目的 對補(bǔ)血益母丸干膏粉進(jìn)行遺傳毒性試驗，為臨床安全用藥提供依據(jù)。方法 采用組氨酸營養(yǎng)缺陷型鼠傷寒沙門氏菌TA97a、TA98、TA100、TA102、TA1535進(jìn)行細(xì)菌回復(fù)突變（Ames）試驗，采用中國倉鼠肺成纖維（CHL）細(xì)胞進(jìn)行體外染色體畸變試驗，采用ICR小鼠進(jìn)行骨髓細(xì)胞微核試驗綜合評估補(bǔ)血益母丸干膏粉的遺傳毒性。其中，Ames試驗設(shè)50、150、500、1 500、5 000 μg·皿^-1 5個劑量；體外細(xì)胞染色體畸變試驗設(shè)125、250、500 μg·mL^-1 3個劑量；小鼠骨髓細(xì)胞微核試驗設(shè)500、1 000、2 000 mg·kg^-1 3個劑量，每天給藥1次，連續(xù)給藥3 d。結(jié)果 在代謝及非代謝活化條件下（＋S9/-S9），Ames試驗結(jié)果 顯示，補(bǔ)血益母丸干膏粉對各菌株均無明顯或可重復(fù)的誘變性及抑菌性；體外CHL細(xì)胞染色體畸變試驗結(jié)果顯示，補(bǔ)血益母丸干膏粉對CHL細(xì)胞染色體結(jié)構(gòu)畸變率未見有意義的升高；小鼠骨髓細(xì)胞微核試驗結(jié)果顯示，補(bǔ)血益母丸干膏粉對ICR小鼠骨髓細(xì)胞微核率無明顯影響。結(jié)論 補(bǔ)血益母丸干膏粉未見潛在的遺傳毒性。

Objective The genotoxicity study of Buxue Yimu Pill dry ointment powder was carried out, and to provide data for clinical safety medication. Methods Bacterial reverse mutation test (Ames test) was performed with histidine auxotrophic Salmonella typhimurium strains TA97a, TA98, TA100, TA102, and TA1535, Chinese hamster lung fibroblasts (CHL cells) were used for in vitro chromosomal aberration test, and ICR small bone marrow cell micronucleus test was performed in mice to comprehensively evaluate the genotoxicity of Buxue Yimu Pill dry ointment powder. Among them, the Ames test set five doses of 50, 150, 500, 1500, and 5 000 μg·dish^-1. The in vitro chromosomal aberration test set three doses of 125, 250, 500 μg·mL^-1. The mouse bone marrow cell micronucleus test set three doses of 500, 1 000 and 2 000 mg·kg^-1, administered once a day for 3 consecutive days. Results Under metabolic and non-metabolic activation conditions (+S9/-S9), the Ames test results showed that Buxue Yimu Pills had no obvious or reproducible mutagenicity and bacteriostasis to each strain. The Chromosomal aberrations in CHL cells in vitro test results showed that: Buxue Yimu Pills dry ointment powder did not significantly increase the chromosome structure aberration rate of CHL cells. The results of the mouse bone marrow cell micronucleus test showed that Buxue Yimu Pills had no significant effect on the micronucleus rate of bone marrow cells in ICR mice. Conclusion No significant genetic toxicity was observed in the dry ointment powder of Buxue Yimu Pill.

R994.2

湖南省自然科學(xué)基金項目（2021JJ80088）