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@#2,6-dimethylbenzenamine was determined as a genotoxic impurity in lidocaine hydrochloride injection, and 2-chloro-N-(2,6- dimethylphenyl) acetamide was determined as potential genotoxic impurity. An LC-MS/MS method was established to research the profiling of genotoxic impurities in active pharmaceutical ingredients (API), homemade preparation and reference preparation on column Agilent ZORBAX Eclipse Plus C18(4.6 mm250 mm，5 μm). The results show that in the homemade preparation the 2,6-dimethylbenzenamine and the 2-chloro-N-(2,6-dimethylphenyl) acetamide may be degraded under oxidation condition and alkaline condition in addition to the introduction from API preparation process. This study provides guidance for genotoxic risk assessment and prescription process optimization of lidocaine hydrochloride.
RESUMO
Objective To compare the anesthetic effect of atocaine adrenaline injection and lidocaine injec -tion in wisdom tooth extraction .Methods 220 patients with wisdom teeth were selected as the research subjects . According to the random table method ,the patients were randomly divided into research group 110 cases ( a total of wisdom teeth 132,maxillary wisdom teeth 47,mandibular wisdom tooth 85) and the control group 110 cases(a total of wisdom teeth 129,maxillary wisdom teeth 51,mandibular wisdom tooth 78).The research group received atocaine adrenaline injection ,the control group received lidocaine hydrochloride injection .The effects of anesthesia ,VAS score and adverse reactions in the two groups were observed .Results The total effective rate of maxillary wisdom tooth anesthesia in the research group(100.00％) was significantly higher than that in the control group (90.20％),and the difference between the two groups was statistically significant (χ2 =6.358,P<0.05).The total effective rate of mandibular wisdom tooth anesthesia in the research group (100.00％) was significantly higher than that in the control group(92.31％),and the difference between the two groups was statistically significant (χ2 =6.788,P<0.05).The VAS score of maxillary wisdom tooth anesthesia in the research group [(2.57 ±0.65)points]was significantly lower than that in the control group [(2.87 ±0.63) points],and the difference between the two groups was statistically significant(t=2.319,P<0.05).In the control group,there was 1 case of hematoma caused by blood vessels ,and no complications occurred in the research group .Conclusion The anesthetic effects of articaine adrenaline injection in wisdom tooth extraction is better than lidocaine hydrochloride injection , without any complications , it is worthy of clinical promotion .
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Objective To improve the quality control standard of lidocaine hydrochloride injection .Methods A method for determination of related substances in lidocaine hydrochloride injection was established .Lidocaine hydrochloride was as‐sayed by HPLC .The chromatographic conditions :C18 chromatographic column was used .The mobile phase was phosphate buffer and acetonitrile (50∶50 ,adjusted to pH 8 with phosphoric acid) .The detection wavelength was 254 nm .Results Ac‐cording to the result of method verification ,related substances could be examined by HPLC .Lidocaine hydrochloride was as‐sayed by HPLC ,which showed excellent linearity at the range of 373 .62‐3 736 .19 μg/ml .The average recoveries were 102 .1% (RSD=0 .9% ) .Conclusion The improved standard could be used to control the quality of lidocaine hydrochloride injection .
RESUMO
OBJECTIVE:To establish a bacterial endotoxin test for compound diclofenac sodium and lidocaine hydrochlo?ride injection(CDL).METHODS:The limitation of endotoxin in CDL was determined and a interference test was performed to determine the maximum non-interference concentration.RESULTS:CDL could interfere the detection of bacterial endotoxin,which could be overcome through300-fold dilution of the preparation.CONCLUSION:The bacterial endotixin test can be used to replace the detection of pyrogen in CDL.