| In recent years, the adverse reaction of traditional Chinese medicine injection hasbeen widely concerned. There are many factors of adverse reaction of traditional Chinese medicineinjections, such as the complexity of the composition in traditional Chinese medicine injections, the toxicity and dosage of each drug in the injection, and the interactionbetween the different components; however, the adverse reactions caused by the "supportingmaterials" in the injections may has little been concerned. Polysorbate 80 is commonly used in the traditional Chinese medicine injections as solubilizing excipients for pharmaceutical productions,currently polysorbate 80 of has a lot of varietiesof which the quality is uneven, and is lack of quality standard to carry on the supervision. Therefore, it is necessary to pay attention tothe quality assessment of polysorbate 80 and study the potential factors which may cause adverse reactions by polysorbate 80 in preparation, so as to ensure the safety and efficacy of traditional Chi-nese medicine injections.1 To establish a method for simultaneous determination of 5 kinds of volatile impuritiesin polysorbate 80.Ethylene oxide, dioxane, ethylene chlorohydrin, ethylene glycol and diethylene glycol are the by-products of produced in the synthesis process of polysorbate 80, each of them have been proved certain toxicity to the human body. Therefore, to establish a gas chromatographic method to determine the five impurity at the same time is important. SelectPEG20000 as stationary phase for the capillary column. The column temperature was 50℃ at beginning, and programmed to 200℃ at a rate of 5℃·min-1, maintained for 10 min; then programmed to 230℃ at a rate of 50℃-min-1 and held for 20 min. The temperature of the injector and detector were set at 200℃ and 250℃, respectively. Collect the different polysorbate 80 samples from different manufacturers both domestic and foreign, dissolved in ethanol, thenthe determine the five volatile impurities at the same time by GC. The results show that, this method is sensitive, accurate, reproducible, and can be used for the quantitative analysis of the five volatile impurities in polysorbate 80.2 The effects of steril ization temperature on the stability of polysorbate 80.In the production of traditional Chinese medicine injections, sterilization is a critical step in the whole process, the level of sterilization can have a direct impact on the safety of injections. In this study, heating temperature was 100℃,116 ℃ and 121℃ based on the sterilization temperature noted in appendix XVI(sterilization) of 2010 edition of" Chinese Pharmacopoeia" and related references, and 0.5h, 1h,2h was selected as the heating time in this investigation. Sample was sealed and heated in a headspace injection gas bottle.The results showed that different heating conditions have different effect on the content of five kinds of harmful substances in the polysorbate 80. Heating for 0.5h at different temperatures, no significant difference of the content of harmful substance was discovered in the samples; content of two harmful substance increased have as follows:sample A heated at 116℃(1h,2h); sample A heated at 121 ℃(1h,2h); sample B heated at 121℃(1h). In addition, heated at 100 ℃ (2h)can cause the increase of the content of only one harmful substance. Therefore, under the condition of a standard sterilization effect, sterilization temperature under 100℃ is relatively safe;if the sterilization temperature is higher than 100℃, the sterilization time shouldnot to exceed 0.5h.3 The determination of unknown components in polysorbate 80 by GC-MS.Because of the complicated composition in polysorbate 80, it is easy to produce kinds of by-products in the producing process. in the early study of the established measurement of five volatile impurities in polysorbate80 by gas chromatography,many unknownchromatographic peaks were observed in spite of the target impurities.In order to improve the detection and control of impurities in polysorbate 80, it is necessary to adopt the GC-MS method to identify the unknown composition.The analysis results show that, in spite of two known impurities were identified by gas chromatography, other polymers and long chain fatty acids, especiallysweet alcohol can be detected in the samples by GC-MS, such as diethylene glycol, triethylene glycol and tetraethylene glycol. In the domestic produced samples, oleic acid, palmitic acid, decanoicacid, pentanoic acid, heptanoic acid, heptyl ketone,heptanal, amyl alcohol, aldehyde,ketone, and other substanceswere detected. These substances has a certain toxicity and irritationto human body, so it is necessary for a further research on the composition of polysorbate 80, and the relevant departments should be suggestedto standardize the quality management andstrengthen the supervision on the manufacturing of polybate 80.4 Determination by DSCDSC is one of the important means to evaluate the purity of drugs in drug analysis, this method is simple and fast. In theory, presence of trace impurities in pharmaceutical samples could cause the melting point or other indicators change in the DSC test accordingly. In this study,8 polysorbate 80 samples from different manufacturers were purchase and tested by DSC. The results shows, different polysorbate 80 samples have different melting temperature, which melting ranged from-7.7～1.2℃,indicating that thequality of polysorbate 80 samples in currentmarket is complex, so it is urgent to develop a relevant standards which can strictly control the quality in order to avoid the occurrence of adverse drug reactions.
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