The Study Of Preparation Process And Contents Determin-Ation For Renshenqiangxin Dropping Pill

Renshenqiangxin Dropping Pill is composed of Ginseng,Salviae, Rehma-nniae,Bufonis, guideing of TCM theory, using the modern preparation techno-logy, according to the Chinese herbal medicine new medicine technicalrequirements, using scientific methods extraction, drop from the system oftraditional Chinese medicine compound preparations, have efficacy of yiqiyangyin,huoxueqiangxin,indications chronic cardiac insufficiency, satisfactoryclinical effect.The study is to establish the extract technology of Salviae andRehmanniae.Orthogonal design is used to establish the optimum preparationprocess for Renshenqiangxin Dropping Pill, establishing the method of deter-mining the contents of four effective components in RenshenqiangxinDropping Pill.Object: To establish the extract technology of Rehmanniae and Salviaefor Renshenqiangxin Dropping Pill. Orthogonal design is used to establish theoptimum preparation process for Renshenqiangxin Dropping Pill,the soliddispersion technique is used to preparate drppping pills. To establish HPLCmethods for determination of the contests of Ginseng Salviae,Rehmanniae,Bufonis in Renshenqiangxin Dropping Pill and make ensure thatclinical treatment effect of Renshenqiangxin Dropping Pill.Methods:1.The bestest extract technology of Rehmanniae: orthogonaldesign was performed to select the water,the decoct time, the decoct times thewater amount; The HPLC used by the the contest of Catalpol.2.The bestestextract technology of Salviae: Salvianolic acid B and Tanshinone ⅡA wereselected as marker components and determined by HPLC to optimize theintegration extract process of Salvia miltiorrhiza by orth-ogonal designtest.3.The optimum preparation process of Renshen-qiangxin Dropping Pill:orthogonal design was performed to select the proportion of adding drug,proportion of matrix PEG4000-PEG6000,the temperature of drug and theheight of freeze-pillar.The weight variation, resolving time, hardness and roundness were used as criteria in the best dropping condition.4. The methodof determining the contents of Gin-senoside Rg1in RenshenqiangxinDropping Pill: the HPLC method was used for determining the contents ofGinsenoside Rg1with a column of Agilent ZORBAXDB C₁₈(4.6mm×250mm,5μm),mand with a mobile phase of Acetonitrile-0.05%H₃PO₄(20:80),the speedat1.0mL·min^-1,the detection wavelength at203nm and the columntemperature at25℃.5. The method of determining the contents ofTanshenoneⅡA and Salvianolic acid B in Renshenqiangxin Dropping Pill:The HPLC method was used with a column of Agilent ZORBAXDBC₁₈(4.6mm×150mm,5μm) and the flow rate at1.0mL·min^-1. The mobilephases were methanol-water (80:20) and acetone-methanol-methanoicacid-water (10:30:1:59), respectively with the detection wavelength at270nm and286nm.6. The method of determining the contents of Cinobufagin andRecibufogenin in Renshenqiangxin Dropping Pill: The HPLC conditions usedwere as follows: Agilent ZORBAXDB C₁₈(4.6mm×150mm,5μm),watercontaining0.5%potassium dihydrogen phosphate (adjusted to pH3.2withphosphoric acid)-acetonitrile(45∶55), and the flow rate was1.0mL·min^-1.The detection wavelength was296nm and column temperature was40℃.6.The method of determining the contents of Catalpol in RenshenqiangxinDropping Pill: The HPLC conditions used were follows: Agilent ZORBAXDBC₁₈(4.6mm×250mm,5μm),column-temperature was20℃;water-acetonitrice(99.5:0.5) as mobile phase,flow rate in1.0mL·min^-1,detected wave length at210nm.Results:The optimized preparation process of Rehmanniae was asfollows: the crude drug was extracted three times,40min every time and10times water was added; The integration technique for extracting was obtained:Salvia miltiorrhiza was added with8times alcohol of70%and extracted2.5hours for2times. The optimized preparation process was as follows: ratiobetween drug and base was1:2, PEG4000-PEG60001:1was optimal bases,the temperature of drug solution was80℃, the height of freeze-pillar was120cm. The linear correlation is available between0.00104mg·mL^-1and 0.1040mg·mL^-1of Ginsenoside Rg1(r=0.9998,n=6),the average recovery ratewas99.10%,the RSD was1.55%. For TanshenoneⅡA, the linear range wasfrom0.021mg·mL^-1-0.210mg·mL^-1(r=0.9999,n=7), the average recoverywas98.71%and RSD was2.55%. For Salvianolic acid B, the linear range wasfrom0.0192mg·mL^-1-0.1920mg·mL^-1(r=0.9993,n=8), the average recoverywas97.86%and RSD was2.21%. For Cinobufagin, the method had goodlinear relationship within the range of0.00254mg·mL^-1-0.0508mg·mL^-1,n=7,The average recovery was99.90%, and RSD was1.01%. ForRecibufogenin, the method had good linear relationship within the range of0.00248mg·mL^-1-0.0496mg·mL^-1n=7the average recovery was99.54%, andRSD was0.59%. The contest of Catalpol showed a good liner relationship at arang of0.1012-1.012mg·mL^-1,n=6, The average recovery standard deviationwas99.68%,and RSD was1.24%.Conclusion:The liposoluble and water-soluble active components ofRehmanniae and Salviae can be extracted simultaneously by the novelextraction process which was reasonable and feasible. This new technique canbe employed to reduce time, working and energy, and be suitable for themorden production. The dropping pills made by this technology had goodproperties of shaping and small weight deviation. This method is suitable forthe preparation of Renshenqiangxin Dropping Pill and industial production.Through this research, foundate the industrial laid a foundation forRenshenqiangxin Dropping Pill and provide the basis For TCMmodernization.