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Objective To explore the the analytical method for the quality difference of Radix Salviae Mihiorrhizae (RSM) injection. Methods Parallel intercomparison experiment was carried out in different batches of RSM injection samples which had different degrees of adverse drug reaction. The samples were analyzed by gel size exclusion chromatog-zraphy and C18 HPLC fingerprint. Subtractive analysis was used to reveal the information of the non-low molecular weight phenolic acids. Results There were obvious differences between the results of size exclusion chromatography. The amount of the non-low molecular weight phenolic acids from different batches of the samples was also different, which was correlated with the degrees of acute toxicity in guinea pigs. Conclusion The amount of the non-low molecular weight phenolic acids varies with different batches of Radix Salviae Mihiorrhizae injection. It is suggested that non-low molecular weight phenolic acids can be used for the quality control of Radix Salviae Mihiorrhizae injection. For the first time, the perspective that the corresponding relationship between the fingerprint and their toxicities of Traditional Chinese medicine injection may be one of the most important fields is put forward.
ABSTRACT
Objective To establish a method for the content determination of baicalin in Jian' er Xiaosi Oral Liquid.Method A HPLC method was adopted.The chromatography conditions were as follows:Prodigy ODS(150 mm? 4.6 mm,5 ? m)served as stationary phase and methanol-water-glacial acetic acid(v/v,47:53:1.5)as mobile phase,the detection wavelength was 280 nm,column temperature 35 ℃ and flow rate 1.2 mL/min.Results The amount of inlet baicalin had a good linearity with the response value of peak area in the range of 0.284～ 3.540 ? g,r=0.999 9.The average recovery of baicalin was 100.33 % and RSD was 0.58 %(n=6).Conclusion This method is simple,rapid,reliable,reproducible,and can be used for the quality control of Jian' er Xiaosi Oral Liquid.
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Objective To investigate the allergic reaction of Shuanghuanglian Injection(SI)and chlorogenic acid.Meth- ods The sensitization of SI was evaluated by observed the systemic active allergic reaction on guinea pigs.The homogeneous and heterogenic passive skin allergic reactions in rats,mice and guinea pigs were observed to compare the sensitationz of SI and chlorogenic acid.Results The possibility of SI causing allergic reaction was higher than that of chlorogenic acid.Con- clusion It is suggested that the possibility of SI as a compound arising adverse reactions be higher than that of chlorogenic acid.
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Objective: To establish the method for determination of taurocholic acid in the Traditional Chinese Medicine Shedanchuanbei Oral Liquid and snake bile. Methods: The sample was prepared as mixed solution containing methanol and KH 2PO 4. The mixed solution was injected into Sep Pak C 18 cartridge for the purpose of sample purity. In this processing, the substances which having strong retain action and could harm analytic column were hold in the Sep Pak C 18 cartridge. The eluting solution that the Sep Pak C 18 cartridge had be over loading for taurocholic acid was used as the test solution. The test solution was measured by RP HPLC. The chromatographic conditions were as followed: Supelcosil LC 8 column(150mm?4.6nm,5?m) as analytic column, detect wavelength at 203nm, and MeOH 0.4%KH 2PO 4 mixed solution(56∶44, V/V ) as mobile phase. The inject volume was 50?L. Results: The linear response range of sodium taurocholate was from 0.0253mg?mL -1 to 0.253mg?mL -1 , and the correlation coefficient was 0.9999. The average recovery rate was 101.3%, RSD was 0.40%( n =6). Conclusion: This method was simple, efficient and suitable to the quality control for Shedanchuanbei Oral Liquid and snake bile.