ABSTRACT
OBJECTIVE：To establish an HPLC fing erprint of Ginsen g Radix et Rhizoma Rubra ，and to optimize its processing technology. METHODS ：HPLC method was adopted. The determination was performed on Waters SymmetryShield TM RP18 column with mobile phase consisted of acetonitrile-water （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was set at 30 ℃，and the detection wavelength was 203 nm. The sample size was 10 μL. Using ginsenoside Rb1 as reference peak ，HPLC fingerprints of 10 batches of Ginseng Radix et Rhizoma Rubra was established. The similarity of them was evaluated by using Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 A edition ） to confirm common peak. With steaming temperature，time and drying method as factors ，using the content of ginsenoside and fingerprint similarity as index ，the processing technology was optimized with L 16（43）orthogonal test design and verified. Cluster analysis was conducted with SPSS 19.0 statistical software of 10 batches of Ginseng Radix et Rhizoma Rubra and 3 batches of optimal processed sample. RESULTS ：There were a total of 13 common peaks in the fingerprints of 10 batches of Ginseng Radix et Rhizoma Rubra. The similarity was more than 0.920；3 common peaks were identified ，such as ginsenoside Rg 1，ginsenoside Re ，ginsenoside Rb 1. The optimal processing technology included that steamed at 100 ℃ for 150 min，dried at 60 ℃. The results of validation test show that the contents of ginsenoside Rg 1，Re and Rb 1 were 0.26％-0.29％，0.17％-0.20％，0.47％-0.54％，and the similarity between 3 batches of Ginseng Radix et Rhizome Rubra optimal processed sample and the control fingerprints was more than 0.970. The results of cluster analysis showed that 10 batches of Gimseng Radix et Rhizoma Rubra and 3 batches of optimal processed sample could be clustered into two categories；HS3-HS10 could be clustered into one category ，and 3 batches of optimal processed sample ，HS1 and HS 2 be clustered into one category. CONCLUSIONS ：Established fingerprint can be used for the optimization of processing technology of Gimseng Radix et Rhizoma Rubra ，and characterize the correlation between f luctuation of technology parameter and quality of medicinal material；the optimal processing technology is reasonable an d
ABSTRACT
In this research,Microtox technology was used to evaluate the comprehensive toxicity of Shen-Fu injection,which was an exclusive product of the pharmaceutical company.Firstly,vibrio fischeri was used as test strain.The best test system and methodology were identified.Under the best test conditions,vibrio fischeri was firstly used in the luminescent bacteria comprehensive toxicity of the exclusive product Shen-Fu injection.The results showed that in the 2 mL reaction system,the best recovery liquid volume was 0.9 mL/ freeze-dried vial,50 μL bacterial suspensions/ sample,the detection time was 10 min after adding bacterial suspensions,the pH was 5-10,the luminous intensity was 800 000-12 000 000 for 10 rin.The RSD of replication experiment and intermediate precision test was ? and ?,respectively,which fitted to the requirements.There was no significant difference on EC50 values among 9 batches of tested Shen-Fu injection (41.07％,RSD ＜ 5％).It was concluded that there was significant concentration-effect relationship between Shen-Fu injection and the toxicity of vibrio fischeri.There was no significant difference on EC50 values among different batches.It indicated that there was small quality volatility among different batches of Shen-Fu injection.The control on product manufacturing was strong.