| ShenmeiYangwei Granules, as a novel formula made from the modern preparation technology, consists of Taraxacum, Glycyrrhizae radix et rhizome, Inulae radix, Salviaemiltiorrizae radix et rhizome, Paeoniae radix alba and other six herbs, viaing water decoction (twice, the first at least ten times the amount of water, the second at least five times the amount of water, decoction time with the original standard for 3 hours)、Concentration (the relative density with the original standard of clear cream was 1.30 (90-95 ℃))and drying process. The formula has the effects such as " nourishing YIN and Harmonizing stomach ".Herce it is used to treat or cure superficial gastritis, stomach YIN deficiency gastritis and all kinds of symptoms of upset stomash and so on There are different specifications for each bag:(1) 16g (2)5g (Sugar Free). Due to the breed standard of quality control program too simple, the quality of the products of the companies on the market there is a big difference, so it is necessary to improve its quality standard.In this paper, the quality standard of Shenmei Yangwei Granules improved were studied.The standard is improved respectively from the specification and uniform prescription and preparation, thin layer identification, content determination and fingerprint, and extracted reproducibility good results to establish the quality standard.The specification and uniform prescription and preparation was confirmed as followed: Prescriptions of Coastal glehnia root is 70 g, secondary water added in decoction for 10 times as well as the five times, each time the decocting time with the original standard for 3 hours, the relative density with the original standard of clear cream was 1.30 (90-95 ℃), auxiliary materials with the original standard is dextrin and sucrose, but changed to’moderate’ addition amount, made a total of 1000g.TLC was used respectively for the preparation of raw material angelica sinensis, dandelion, licorice and other ingredients for qualitative identification, respectively is accompanying control with the comparison and contrast medicinal plants. RESULTS: Dandelion, licorice has good repeatability and reproducibility,29,28 batch of samples detected respectively dandelion, licorice, therefore two T are included in the draft standard; Angelica ingredients, civil taste fragrant ingredients and safflower there is interference due to the negative and not included in the draft standard. Using HPLC method for the preparation of alantolactone and isoalantolactone, controlling 2 reference substance at the same time, using C18 column separation, acetonitrile-0.1% phosphate solution (50:50) as mobile phase, detection wavelength of 225 nm. RESULTS:30 batch sample inspection alantolactone and isoalantolactone, included in the draft standard.Content determination by HPLC method for simultaneous determination and nourishing Salvianic acid A sodium in Salviae miltiorrizae radix et rhizoma and paeoniflorin in Paeoniae radix alba.RESULTS:The qualitative identifications have good specifications without interferences in the negative references. For quantitative analysis, Salvianic acid A sodium and Paeoniflorin were in good linear relationship showing r value of 1.000 and 0.9995 (n=8) with linear range of 40.5-506.25μ.g and 50.19-627.38μg respectively. Reproducticities of both components were RSD of 0.4% and 1.7%(n=12), their mean recoveries were 97.16% and 99.83% with RSD of 1.51% and 0.62%(n=6). Theoretical plate number is 5000. The content of Salvianic acid A sodium and Paeoniflorin were 4.560mg/bag(RSD=24.7%, n=4) and 12.191mg/bag(RSD=18.8%, n=4). Experimental methods on different brand chromatographic column instruments with good reproducibility. The lower limit of content were that the content of Salvianic acid A sodium was not be less than 3.5mg/bag and the content of Paeoniflorin was not be less than 9.4mg/bag.The research established a sensitive and specific HPLC fingerprints method and get the control chromatogram to evaluate the quality of ShenmeiYangwei Granules.The fingerprint of ShenmeiYangwei Granuleswas performed on Waters Symmetry C18(250mmx4.6mm,5μm) with acetonitrile.01% formic acid as gradient mobile phase.the flow rate was set at 1.0mL?min-1. The detection wavelength was set at 245 nm and the column temperature was maintained at 30 ℃. Traditional Chinese medicine chromato graphic fingerprint similarity evaluation system (2012.1 Edition) by State Pharmacopeia Committee of China was used to evaluate the similarity of 27 batches of ShenmeiYangwei Granules. The liquid chromatography-mass spectrometry-ion trap-time-of-flight (LCMS-IT-TOF) method was applied to analyze the fingerprint of ShenmeiYangwei Granules. Multistage mass spectrometry data of different compounds was obtained by using dldctrospary ionization source and monitoring in positive and negative ion modes. RESULTS:The precision of sample was good and the RSD (n=6) values of relative retentiontime and relative area were no more than 0.61% and 2.48%, respectively.The reproducibility of sample was good and the RSD values of relative retention time and relative area were no more than 0.09% and 2.53%, and the test solution was stable in 48 hours(the RSD (n=16) values of relative retention time and relative area were no more than 0.38% and 2.84%). Based on the characteristic MS/MS gragment ions data with chemical standards and published literatures, a total of 9 compounds in ShenmeiYangwei Granules were identified or tentatively characterized, including 1 (gallic acid),5 (SalvianicacidAsodium),9 (Albiflorin),10 (Paeoniflorin),11 (Liquiritin), 12(Galloylpaeoniflorin or Galloylalbiflroin or their isomers),13(Rosmarinic acid),14 (decarboxylate of Lithospermic acid),15 (Salvianolic acid B). Fingerprint may provide more effective means for the quality control of ShenmeiYangwei Granules. |
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