1.Cytotoxicity of Ibuprofen Raw Material and its Part of Impurities
Yang WANG ; Kaiyong HE ; Jiate SHEN ; Yating YANG
China Pharmacist 2017;20(4):769-771
Objective:To evaluate the cytotoxicity of ibuprofen and its 6 kinds of impurities.Methods:Different concentrations of ibuprofen and the impurities were used to act on mouse fibroblasts (L929) for 72 h,and the cytotoxicity was observed under a microscope.Results:In ibuprofen raw material,the cytotoxicity of impurity B was the weakest with slight toxicity,the cytotoxicity of impurity N,D,J and V was moderate,and that of impurity E was severe.Conclusion:At the same concentration,the toxicity of impurity E is the strongest,and its content in ibuprofen preparations should be strictly controlled.
2.Study on Antimicrobial Effectiveness of Zhenzhu Mingmu Eye Drops
Jiate SHEN ; Xuan YI ; Xiaoling XU ; Yang WANG ; Xiang LU
China Pharmacist 2015;(6):894-896
Objective:To evaluate the antimicrobial effectiveness of Zhenzhu Mingmu eye drops according to the requirements de-scribed in Chinese pharmacopoeia (2010 edition). Methods:Totally 7 batches of Zhenzhu Mingmu eye drops from 7 enterprises were evaluated. All the samples were tested according to the requirements described in Chinese pharmacopoeia, and the testing points of 6h and 24h were added. Results:As for bacteria, the reduction value of staphylococcus aureus in 7 days treated with Zhenzhu Mingmu eye drops from enterprise e was 0. 61g, and that in 14 days was 1. 01g. That in 7 days treated with the eye drops from the other enter-prises was all above 1. 01g, that in 14 days was above 3. 01g, and that in 14-28 days kept stable. As for fungi, the number was stable from the beginning with the treatment of the eye drops from the seven enterprises. Conclusion:Although the type and content of bacte-riostatic agent in domastic Zhenzhu Mingmu eye drops are the same, there is difference in the antimicrobial effectiveness of the product from different enterprise. The eye drops from one enterprise can't meet the requirements for type I product described in Chinese pharma-copoeia,and the others meet the requirements.
3.Investigation on the depressor substance tests method of coenzyme complex for injection
ZHANG Ju ; LÜ ; Xiaojun ; ZHOU Daqing ; SHEN Jiate ; HE Kaiyong
Drug Standards of China 2024;25(1):072-075
Objective: To observe the acute hypotensive effect of compound coenzyme for injection on cats,and to establish a method for examination of depressor substance.
Methods: Ten batches of compound coenzyme for injection and histamine depressor substance were compared by cat blood pressure method to determine the limit value of depressor substance test method. According to the limit value, 22 batches of samples were tested for depressor substance.
Results: The limit of compound coenzyme for injection was 3 IU·kg-1 (calculated by coenzyme A). Two batches of 22 batches of compound coenzyme for injection did not meet the requirements.
Conclusion: The method of compound coenzyme for injection is feasible according to the proposed limit value. It is suggested that the quality standard of compound coenzyme for injection should be added with the examination of depressor substance.
4.Genotoxicity of Sanqi Liver-protecting Capsules
Yang WANG ; Kaiyong HE ; Jiate SHEN ; Yan WANG ; Xiaojun LV
China Pharmacist 2017;20(10):1749-1752
Objective:To study the acute toxicity and genotoxicity of Sanqi liver-protecting capsules to evaluate the toxicological safety. Methods:The mouse acute oral toxicity test, Ames test, micronucleus test of mouse bone marrow and mouse sperm shape ab-normality test were carried out for Sanqi liver-protecting capsules. Results:The mouse acute oral maximum tolerance dose ( MTD) of Sanqi liver-protecting capsules was above 20 g·kg-1 in the mouse acute oral toxicity test, which showed a non-toxic substance. The results of Ames test, micronucleus test of mouse bone marrow and mouse sperm shape abnormality test were negative in all the groups. Conclusion:Under the above experimental conditions,the genotoxicity of Sanqi liver-protecting capsules is not found out, therefore, the capsules are classified as a non-toxic drug.
5.Genotoxicity of Sanqi Liver-protecting Capsules
Yang WANG ; Kaiyong HE ; Jiate SHEN ; Yan WANG ; Xiaojun LV
China Pharmacist 2017;20(10):1749-1752
Objective:To study the acute toxicity and genotoxicity of Sanqi liver-protecting capsules to evaluate the toxicological safety. Methods:The mouse acute oral toxicity test, Ames test, micronucleus test of mouse bone marrow and mouse sperm shape ab-normality test were carried out for Sanqi liver-protecting capsules. Results:The mouse acute oral maximum tolerance dose ( MTD) of Sanqi liver-protecting capsules was above 20 g·kg-1 in the mouse acute oral toxicity test, which showed a non-toxic substance. The results of Ames test, micronucleus test of mouse bone marrow and mouse sperm shape abnormality test were negative in all the groups. Conclusion:Under the above experimental conditions,the genotoxicity of Sanqi liver-protecting capsules is not found out, therefore, the capsules are classified as a non-toxic drug.