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AIM To establish an HPLC method for the simultaneous content determination of chlorogenic acid,caffeic acid,luteoloside,baicalein,luteolin and rutin in Yinhuang Granules (Lonicerae japonicae Flos and Scutellariae Radix extracts).METHODS The analysis of 80％ methanol extract of this drug was performed on a 30 ℃ thermostatic SunFire-C1scolumn (250 mm × 4.6 mm,5 μm),with the mobile phase comprising of acetonitrile0.4％ phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 239 nm.RESULTS All the six constituents showed good linear relationships within their own ranges (r =0.999 9),whose average recoveries were 94.56％-98.38％ with the RSDs of 0.49％-2.89％.Among fourteen batches of samples,the luteoloside content was found to be of little difference,while the other five constituents' contents were of relatively great differences.CONCLUSION The qualities of Yinhuang Granules and Lonicerae japonicae Flos extracts from different manufacturers are uneven,so supervision should be strengthened.
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OBJECTIVE:To establish a method for the simultaneous determination of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen in Yaotong capsules.METHODS:HPLC method was adopted.The determination was performed on Agilent-C18 column with mobile phase consisted of acetonitrile-water (gradient elution) at the flow rate of 1.0 mL/min.The detection wavelengths were set at 240 nm (paeoniflorin,psoralen,isopsoralen) and 290 nm (cinnamaldehyde).The column temperature was 35 ℃,and sample size was 10 μL.RESULTS:The linear ranges of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen were 0.004 02-0.100 6 mg/mL(r=0.999 8),0.024 50-0.612 7 mg/mL(r=0.999 8),0.005 24-0.131 0 mg/mL(r=0.999 9),0.005 11-0.127 8 mg/mL(r=0.999 9),respectively.LOQ were 37.17,1.47,21.76,25.57 ng,respectively;LOD were 11.15,0.44,6.53,7.67 ng,respectively.RSDs of precision,stability and reproducibility tests were all lower than 2.0％.The recoveries were 99.02％-100.83％ (RSD=0.68％,n=6),98.58％-100.99％ (RSD=0.83％,n=6),99.78％-101.69％ (RSD=0.89％,n=6),100.06％-102.46％ (RSD=0.92％,n=6),respectively.CONCLUSIONS:The method is simple,accurate and suitable for simultaneous determination of paeoniflorin,cinnamaldehyde,psoralen and isopsoralen in Yaotong capsules.
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OBJECTIVE:To evaluate the dissolution curves similarity of generic and original preparation of Losartan potassium tablets,and to provide reference for improving quality evaluation of the preparation.METHODS:Using hydrochloric acid solution (pH 3.0),phosphate buffer solution(pH 4.5),phosphate buffer solution (pH 6.8) and water as medium,paddle method was adopted for dissolution test with dissolution medium volume of 900 mL and rotation speed of 50 r/min.UV-visible spectrophotometry was adopted to determine accumulative dissolution of generic and original preparation of Losartan potassium tablets with the detection wavelength of 256 um.The similarity of dissolution curves were evaluated by calculating similarity factor(f2).RESULTS:The linear range of losartan potassium was 12.11-35.96 μg/mL (r≥0.999 7).RSDs of precision,stability and reproducibility tests were all lower than 5.0％.The recoveries of 4 dissolution media were 98.66％-100.84％ (RSD=0.77％,n=9),98.91％-100.59％ (RSD=0.49％,n=9),98.33％-101.39％ (RSD=0.85％,n=9),99.46％-101.32％ (RSD=0.55％,n=9).In 4 dissolution media,f2 of the dissolution curves of 3 batches of generic and original preparation of Losartan potassium tablets were all higher than 70.CONCLUSIONS:The dissolution curves of self-made and original preparation of Losartan potassium tablets show good similarity.
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Objective To measure the lethal dosage values ( LD50 ) of i.v.asarone injection for mice and to establish a standard for abnormal toxicity test of asarone injection to potentially reduce the occurrence of adverse drug reaction.Methods To obtain the LD50 value, a weighted linear probit regression method ( Bliss method) is employed. The limit of abnormal toxicity test is determined according to Appendix XI C in its 2010 edition of the Chinese pharmacopoeia.Results It is found that the LD50 of intravenously asarone injection in mice ranges from 51.9 to 153.1 mg/kg.The abnormal toxicity test should be added as an additional item in the standard.Conclusions Based on analyses in this study, an appropriate limit of abnormal toxicity test is 15 mg/kg, which is also in line with current medical standard in China.
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Objective: To establish a determination for Ricinus communis L.and Carthamus tinctorius L.could in Anchan Emulsion. Methods: The determinations were carried out by GC. Chromatographic conditions were: using Chromosorb DEGS as a stationary phase column temperature 180 ?C , flame ionization detecter.Rusults:The content limit of Linoleic acid wasn't lower than 20%, The content limit of Ricinoleic acid wasn't lower than 20%.Conclusion: The established methods is simple, feasibl and reproducible. This study provides a method for the quality control of Anchan Emulsion.
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AIM:To establish a qualitative fingerprint analysis with capillary GC. METHODS:HP-INNOWAX column(30 m?0.53 mm,1.0 ?m),column temperature:90 ℃(15 min)4 ℃/min180 ℃(5 min)2 ℃/min200 ℃(3 min)10 ℃/min220 ℃(5 min),FID detector temperature:230 ℃. RESULTS:Compared with reference peak of Sec-butyl-cis/trans-1-propentyl disulfide,17 common peaks on fingerprints of the oil from ferula sinkiangensis K.M.Shen were indicated by the method with satisfied stability,precision and repeatability. CONCLUSION:There are good similarities among 10 batches of essential oil from Ferula sinkiangensis K.M.Shen,and this method is reliable,simple and provides a reference standard for the quality control of Ferula sinkiangensis K.M.Shen.
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Objective: To establish the quality standards for Xiegananshen Capsules. Methods: Poria in this prescription was identified by microscopic examination; Radix Gentianae, Fructus Gardeniae, Radix Angelicae Sinensis and Radix Scutellariae were identified by TLC. Gentiopicrin was determined by HPLC. Results: Poria could be detected by microscopic examination; Radix Gentianae, Fructus Gardeniae, Radix Angelicae Sinensis and Radix Scutellariae could be detected by TLC. Gentiopicrin showed a good linear relationship at a range of 2.6 ～13?g, r=0.9995. The average recovery was 97.8%, and RSD was 1.0%. Conclusion: The established methods are simple, feasible and reproducible. This study provided a method for the quality control of Xiegananshen Capsules.