5.Determination of residual organic solvents in Ginkgo biloba Leaves for injection by headspace GC
Teng WANG ; Yifang YANG ;
Chinese Traditional Patent Medicine 1992;0(05):-
Objective:To establish a method for analysis of residual organic solvents (methanol, ethanol, acetone, ethyl acetate) in Ginkgo biloba Leaves for injection.Methods: The contents of residual solvents in Ginkgo biloba Leaves for injection were determined by headspace GC on HP 5 column, with FID detector, high purity nitrogen as the carries gas.Results: There was a good linearity ( r :0.9909~0.9999). The RSD of precision and accuracy was less than 5%, the average recovery rate was in the range of 93.06%~113.78%.Conclusions: The method was simple, quick and accurate and can be used for quality control of Chinese patent medicine.
8.Quality standard of Yuquan Micropill
Chinese Traditional Patent Medicine 1992;0(08):-
AIM:To establish the quality standard of the composition of Yuquan Micropill(Radix Rehmanniae,Fructus Schisandrae Chinensis,Radix Puerariae lobatae,etc.). METHODS: The composition of Yuquan Micropill were identified by TLC and the content was determined by HPLC.Puerarin could be separated through Diamonsil~(TM) C_(18) column(5 ?m,250 mm?4.6 mm) with methanol-water(1.2∶3 by volume) as a mobile phase.The flow rate was 1.0 mL/min,the detection wavelength was set at 250 nm and the column temperature was maintained at 40 ℃.?-Schizandrin could be separated through Kromasil KR100-3.5 C_(18) column(100 mm?4.6 mm) with methanol-water(3.5∶1 by volume) as a mobile phase.The flow rate was 0.6 mL/min and the detection wavelength was set at 254 nm. RESULTS: The spots in the TLC were clear and could be well separated,the blank and adjuvant contrast could not be interfered.HPLC showed a good peak form,good resolution and could not be interfered by the foreign matter.The average recovery of puerarin was 99.24%,RSD=0.84%,RSD of precision was 0.95%,RSD of reproducibility was 0.86%,RSD of stability was 0.44%.The average recovery of ?-schizandrin was 99.74%,RSD=0.78%,RSD of precision was 1.89%,RSD of reproducibility was 1.76%,RSD of stability was 1.82%. CONCLUSION: The method is simple and has good resolution,strong specificity and good reproducibility,It can be used for the quality control of the composition of Yuquan Micropill.
10.Retrospection,stratagem,and practice on innovative drug research and development of Chinese materia medica
Yifang YANG ; Bicheng YANG ; Lili JIN
Chinese Traditional and Herbal Drugs 1994;0(10):-
Taking the national key scientific and technological project in 11th Five-year and 10th Five-year Plan as its main clue,the innovative Chinese materia medica(CMM)research course has been reviewed in this paper.Based on the enlightenment from the first herbal medicine VeregenTM,which has been approved by FDA,together with the study and comprehension of many great achievements of new drug research,the strategy of innovative CMM research and development(R&D)and its practical route is going to be put forward in this article.With the innovative Compound Prescription of CMM research as the main innovative approach,innovation can be realized by the following three aspects:New substances,including new compound,new effective fraction/group or new components and their combinations;new indication of known compounds or extracts;the secondary development of high-quality Chinese patent medicine.Besides,in order to support the R & D of original drugs with Chinese characteristics,the international experiences in target-dependent screening and evaluation and optimization of leading compounds based on clinical application should be referenced,and the mechanism and targets of traditional Chinese medicine by genetic and molecular level be clarified.