RESUMEN
Injectable traditional Chinese medicine often contains multiple components including undefined toxic substances, can have high variability between batches, with undefined mechanisms of action. It is urgent to improve the quality and consistency and reduce the toxicity risk of traditional Chinese medicine. The Microtox technology is a simple, rapid method for the detection of toxic substances in the environment that uses non-pathogenic luminescent bacteria as an indicator, and the change in luminosity as an index. Using this bioassay we have systematically applied Microtox technology for the detection of microtoxicity in injectable traditional Chinese medicine. As a new method of bioactivity characterization, Microtox technology is expected to be used in the detection of quality fluctuations and toxicity risks at an early stage in the preparation of injectable traditional Chinese medicines and to improve the quality of injectable traditional Chinese medicine.
RESUMEN
In this research,Microtox technology was used to evaluate the comprehensive toxicity of Shen-Fu injection,which was an exclusive product of the pharmaceutical company.Firstly,vibrio fischeri was used as test strain.The best test system and methodology were identified.Under the best test conditions,vibrio fischeri was firstly used in the luminescent bacteria comprehensive toxicity of the exclusive product Shen-Fu injection.The results showed that in the 2 mL reaction system,the best recovery liquid volume was 0.9 mL/ freeze-dried vial,50 μL bacterial suspensions/ sample,the detection time was 10 min after adding bacterial suspensions,the pH was 5-10,the luminous intensity was 800 000-12 000 000 for 10 rin.The RSD of replication experiment and intermediate precision test was ? and ?,respectively,which fitted to the requirements.There was no significant difference on EC50 values among 9 batches of tested Shen-Fu injection (41.07％,RSD ＜ 5％).It was concluded that there was significant concentration-effect relationship between Shen-Fu injection and the toxicity of vibrio fischeri.There was no significant difference on EC50 values among different batches.It indicated that there was small quality volatility among different batches of Shen-Fu injection.The control on product manufacturing was strong.
RESUMEN
This study aimed at exploring the application of microtox technology to the evaluation of comprehensive toxicity of Sheng Mai injections.Characteristic parameters of vibrio fischeri (CS234) were measured by methodology inspection under different conditions to optimize the reaction condition with reliable technology.It was the first experiment to accomplish the comprehensive toxicity of Sheng Mai injections from various manufacturers using vibrio fischeri under the target condition.It was found that parameters of the optimum condition contained 0.9 mL recovery liquid volume in each freeze-dried vial and 50 μ L bacteria suspension of each sample,being included in 2 mL solution in aggregate under 10 mins' detection time after adding bacteria suspension with the favorable pH value ranging from 5 to 10 and luminous intensity from 0.8 to 1.2 million within 10 mins.The relative standard deviation values of replication experiment and precision test were all below 15％.Under this optimum detection condition,it was found that the EC50 values were 22.10％,34.10％ and 46.04％,respectively,presenting significant statistical differences (P＜0.05).These results demonstrated that the growth of biological detection standards of Sheng Mai injection was highlighted a long way to go.Besides,the microtox-based fast test for the evaluation of the comprehensive toxicity of Sheng Mai injection showed a prospective application to controlling the quality of different products from manufacturers.
RESUMEN
In this research,we chiefly explored a new fast test method--microtox technology to evaluate the comprehensive toxicity of Shen Mai injection.We investigated characteristic parameters of vibrio fischeri (CS234) under different conditions in the pursuit of the optimum test parameters of the reliable method;and then locked the best parameters for Shen Mai injection assay with the products from different manufacturers by microtox fast test.As a result,the optimum reaction condition included 0.9 mL recovery liquid in each freeze-dried vial and 50 μL bacteria suspension of each sample within 2 mL solution in aggregate with 10-mins detection after adding bacteria suspension which pH value ranging from 5 to 10 and luminous intensity from 0.8 to 1.2 million in 10 mins.The relative standard deviation values of replication experiment and precision test were all below 15％.Under this optimum detection condition,it was found that the EC50 values were 35.60％,92.34％ and 146.57％,differing among the samples from three representative drug manufacturers,respectively (P ＜ 0.01).In conclusion,the concentration-effect relationship of Shen Mai injection existed in the toxicity assessment of vibrio fischeri with various ECs0 values from the three manufacturers.These results suggested that biological detection standards of Shen Mai injection presented great growth potential.Microtox-based fast test in the evaluation of comprehensive toxicity of ShenMai injection showed favorable application prospects over controlling the quality of different sources of products.
RESUMEN
This study aimed at exploring a new method--microtox technology to evaluate the comprehensive toxicity of safflower injections from different drug manufacturers.In the experiment,we investigated the characteristic parameters of vibrio fischeri (CS234) under different conditions,and then locked the optimum parameters for safflower injection assay:recovery liquid volume 0.9 mL in freeze-dried vial,50 μL bacteria suspension in each sample,and the detection time of 10 mins after adding the bacteria suspension.Under this optimum detection condition,we found that the EC50 values were 3.36％,5.58％ and 4.33％,being significantly different between 3 representative drug manufacturers (P ＜ 0.05).In conclusion,it was implied that the biological detection standards of safflower injections need improving,while the microtox-based fast test of the comprehensive toxicity of safflower injection showed a favorable and prospective application to controlling the product qualities of different manufacturers.
RESUMEN
Microtox technology is one of quick toxicity test methods for determining the poisonous or toxic substances in the environment by luminous bacteria as a indicator organism.This paper reviewed the appearance and development of microtox technology.Besides,we expounded the methods and stepwise technique map and addressed key questions of microtox technology for the evaluation of the comprehensive toxicity of Chinese medicinal materials.In conclusion,microtox technology is a promising method from a vantage point of the toxicity detection of Chinese medicinal materials.