Studies On The Quality Control About Danqi Tables Of Chinese Herbal Drugs Compound Preparations

In recent years, lots of Chinese herbal drugs such as Salvia miltiorrhiza, rhubarb are important for us. Chinese herbal drugs compound preparation is used widely in clinical. Danqi tables comprised of Salvia miltiorrhiza and pseudo-ginseng. Salvia miltiorrhiza is one of the common Chinese herbal. It is considered in Chinese tradition theory that Salvia miltiorrhiza is micro-chilly and micro-bitter in taste, belongs to heare and liver theoty. It has the efficiency of removing blood stasis and alleviate pain activating blood of promote menstruation, clearing away eliminating annoy and heart-fire. According to the statistics, there has been numerous of Salvia miltiorrhiza preparations in current clinical. Western medicine to treat the diseases in the clinical, causing headaches, dizziness, nausea, diarrhea, abdominal distension, skin rashes and other adverse reactions. Compared with Western medicine, studies confirmed that Chinese herbal drugs preparations have not the effect. Some herbal such as Compositae salviae miltiorrhizae makes great therapeutic effect by long-term using.Quality standards are very important for controlling the quality of medicines. Quality standards can control the drug quality effectively and ensure that the drug is safe. Through looking up numbers of literature, it can be found that quality control methods of Salvia miltiorrhiza preparation have been reported. However, some quality control of Salvia miltiorrhiza preparation has not been reported, only one or two active components for quality control has been reported. It can not totally evaluate the quality of these drugs. Furthermore, some quality control methods need to be improved.In order to use the Chinese herbal drugs preparations safely and widely, the quality control becomes the main target for our study. Controllability of the quality of medicines is a fundamental property and a basis of the safety and effectiveness of drugs. Quality standards are the important means of controlling the quality of medicines, which can control the drug quality effectively and ensure the drug safely, and are the concrete embodiment of the quality control. The index components of Danqi tables, Zhikang tablets and Shenqi Wuweizi tablets were selected as the research subjects for the study; High performance liquid chromatography is used to control the compound preparations quality, committed systematic methodology verification and determination. The method had good specificity, precision and stability. The experiment results were accurate and reliable. The test method could provide scientific and effective accordance with control the quality of Chinese herbal drugs compound preparations. Part ? Determination of Salvianic acid Protocatechualdehyde and Salvianic acid B in Danqi Tablets by HPLCObjective: An HPLC method was established for the determination of Salvianic acid, Protocatechualdehyde and Salvianic acid B in Danqi tablets. The method provided a basis for quality control of Danqi tablets.Methods: The method of HPLC was used to determine the content of salvianic acid, protocatechualdehyde and salvianic acid B. Kromasil-C18 column was used with the mobile phase methano-1% acetic acid, the flow rate was 1.0 m L /min and detection wavelength was set at 281 nm.Results: In the above chromatographic conditions, Salvianic acid, Protocatec- hualdehyde and Salvianic acid B had good peak shape without interference of other peaks, the separation of adjacent peaks were more than 1.5, the theoretical plate number was more than 8000. The ranges of the salvianic acid, protocatechualdehyde and salvianic acid B showed good linear relationship, which were 0.202×103~2.02×103ng, 0.0264×103~0.264×103ng, 0.316×103~3.16×103ng, respectively and the regres- sion equations were: Y=0.579x-1.00( r=1.000), Y=3.72x+5.16( r=0.9999), Y=0.609x-6.25(r=0.9999), respect- tively; The precision of the method of RSD values were 0.18%, 0.96%, 1.03%; The reproducibility of RSD values were 0.42%, 0.21%, 0.09%; The stability of the RSD within 12 hours were 0.52%, 0.52%, 0.25%; The average recoveries were 100.6%, 99.6%, 98.9% and the RSD values were 0.51%, 0.87%, 1.2%,(n=6).Conclusions: The method was convenient, accurate and highly sensitive. It can be used to determine the contents of the Salvianic acid, Protocatec- hualdehyde, and Salvianic acid B in Lipid-lowering granules. The method provided a basis for quality control of lipid-lowering granules. Part II Determination of Emodin,Chrysophanol and Physcion in Zhik ang Tablets by HPLCObjective: An HPLC method was established for the determination of emodin, chrysophanol and physcion in Zhi Kang tablets. The method provided a basis for quality control of Zhi Kang tablets.Methods: The method of HPLC was used to determine the content of emodin, chrysophanol and physcion. Diamonsil-C18 column was used with the mobile phase methanol-1% phosphate acid solution(80:20). The column temperature was maintained at 25 ℃. The flow rate was 1.0 m L/min. The detection wavelength was set at 254 nm. The sample size was 20 μL.Results:Under the optimized condition of the selected chromatography,the retention time of emodin,chrysophanol and physcion was at 8.8、13、20min respectively with good resolution and stability;The regression equation of emodin was Y大黄素=3.12×10-5x+0.0790(r2=0.9997)and the calibration curve of emodin was linear in the range of 1.75~17.5μg.ml-1,The average recoveries with high,medium and lowe concentrations were 99.9%(RSD=1.1%,n=3)、102.5%(RSD=0.38%,n=3)、98.1%(RSD=0.80%,n=3)respectively;The regression equation of chrysophanol was Y大黄酚=2.34×10-5x+0.661(r2=0.9998)and the calibration curve of chrysophanol was linear in the range of 11.1~111.0μg.ml-1,The average recoveries with high,medium and low concentrations were 98.5%(RSD=1.25%,n=3)、101.8%(RSD=0.44%,n=3)、99.0%(RSD=0.72%,n=3)respectively;The regression equation of physcion was Y大黄素甲醚=3.01×10-5x+0.246(r2=0.9995)and the calibration curve of physcion was linear in the range of 5.25~52.5μg.ml-1,The average recoveries with high,medium and low concentrations were 99.9%(RSD=0.99%,n=3)、100.6%(RSD=0.80%,n=3)、98.1%(RSD=0.19%,n=3)respectively.Conclusions: In this experiment, a HPLC method is established to determine the content of emodin, chrysophanol and physcion. The method is simple,sensitive,accurate and can be used for the quality control of Zhikang Tablets. Part III Determination of Schisantherin A, Deoxy schizandrin and Quercetin in Shenqi Wuweizi Tablets by HPLCObjective: An HPLC method was established for the determination of schisantherin A, deoxy schizandrin and Quercetin in Shenqi Wuweizi tablets. The method provided a basis for quality control of Shenqi Wuweizi tablets.Methods: The Kromasil C18 column was used with a mobile phase of methanol- 0.1% acetic acid by gradient elution,the flow rate was 1m L·min-1,the column temperature was 30℃, the UV detection wavelength was at 220 nm.The different batches of Shenqi Wuweizi tables were determined the contents of the three index ingredients in tables.Results: In the above chromatographic conditions, schisantherin A, deoxy schizandrin and Quercetin had good peak shape without interference of other peaks, the separation of adjacent peaks were more than 1.5, the theoretical plate number was more than 3000. The linear ranges of quercetin, schisantherin A and deoxyschizandrin were 0.0285×103~0.228×103ng(Y=1.53x+35.9, r=0.9995), 0.297×103~2.37×103ng(Y=6.23x+57.7, r=0.9999), 0.1 89×103~1.51×103ng(Y=6.41x- 5.88,r=1.0000), respectively. The average recoveries of three components were100.8% with RSD=0.69%, 100.6% with RSD=1.2%,99.6% with RSD=0.30%(n=6).Conclusions: The method is simple, accurate, sensitive and it can be a method for quality control of Shenqi Wuweizi tables.