[Objective] This study was conducted to establish a microbial limit test method for Bupi Qiangli Ointment. [Method] The conventional method and medium dilution method were used for bacterial, mold and yeast counting in sample recovery test. [Result] The medium dilution method （1：10 test solution, 0.5 ml/plate） could effectively eliminate the inhibition effect of the Bupi Qiangli Ointment, and the recovery of Staphylococcus aureus was greater than 70% in the 3 batches of samples; and the conventional method exhibited the recoveries of E. coil, Bacillus subtilis, Candida albicans and Aspergillus greater than 70% in the 3 batches of samples. [Conclusion] Due to Bupi Qiangli Ointment has strongly antibacterial effect on Staphylococcus au- reus, the medium dilution method was used for bacterial counting, and the conventional method was used for mold and yeast counting; and the conventional method was used for controlled bacterium examination of E. coll.
[Objective] This study was carried out to provide toxicological basic data for the development and research of Yushen Xiaoyang Lotion.[Method]SPF SD mice, half male and half female, were divided into a blank control group and a Yusheng Xiaoyang Lotion group randomly. The percutaneous acute toxicity of Yusheng Xiaoyang Lotion was observed by one time limited dose method, and ap-parent sign changes and death condition of mice after administration of the drug were recorded. After the test, all the animals were weighed and subjected to gross anatomy, and if there were abnormal phenomena, further histopathological examina-tion of should be done. Animals died during the test should be subjected to anato-my. [Result] All the mice survived and exhibited normal behavior,glossy hair and increase of body weight in accordance with growth law.No local and systematic toxicity responses on skin were observed. In visual observation after dissection, no pathologic changes on heart, liver, spleen, lung and kidney were observed. There were no significant differences in body weight between the Yusheng Xiaoyang Lo-tion group and the blank control group before administration,the 7th d after adminis-tration and the 14th after administration （P〉0.05）. [Conclusion] In the transdermaldrug delivery acute toxicity test of Yusheng Xiaoyang Lotion on mice, no obvious toxic responses were observed under the total dose of 89.70 g/kg （equivalent to 120 times of the clinical daily dose for adults）.
