Study On The Quality Standard Of Jingfukang Granule

Recent years, as the limitation of western medicine were known by usand the risen of returning back to nature worldwide, especially as humanmedical mode turning from curing diseases to the combination of prevetion,health care, treatment and recovery, natural medicines and Traditional ChineseMedicines (TCM) were paid more attention by people. Jingfukang Granuleshined under this background. TCM was a treasure of our country, the key torealize TCM modernization and get into international market was establishingTCM standard which featured Chinese medicine and accepted by internationalsociety.Jingfukang Granule consist of Notopterygium incisum, Ligusticumwallichii, Radix Puerariae, Gentiana macrophylla, radix clematidis, rhizomaatractylodis, Salvia miltiorrhiza, radix paeoniae alba, lumbricus, Safflower,olibanum,Astragalus membranaceus,Codonopsis pilosula,rehmannia,conchahaliotidis, Ophicslcite,phellodendron amurense rupr,Cowherb Seed, PeachSeed, myrrh and ground beeltle. The granules can promote blood circulation toremove meridian obstruction, dispel wind and relieve pain. This prescriptionmainly cure Cerebral Insuffizienz, dizzy, neck stiffness, sore neck andshoulder, etc, which caused by cervical spondylosis. Jingfukang Granule wasthe drug of first choice in curing cervical spondylosis, whose effective ratewere highly90percents. Jingfukang Granule won the majority of consumerrecognition because of its exact curative effect, and it belonged to exclusivevarieties of Jingfukang Pharmaceutical Group Co.,Ltd， national secrettechnology project, national protected traditional medicines, etc. It was carriedin Chinese pharmacopoeia of2005and2010.Recently,the whole standard of large compound preparations need to beimproved. Jingfukang Granule which consist of21kinds of TCM was one oflarge compound preparations. In the existing quality standards-Chinese pharmacopoeia (2010),Salvia miltiorrhiza,radix paeoniae alba, Astragalusmembranaceus and Cowherb Seed were detected and indentified by TLC,thecontent of Puerarin were determined by HPLC.Studying its standard not onlyensure its quality control, but also provide reference to the qualitative researchof other large compound preparations.Notopterygium incisum,Gentiana macrophylla,Radix paeoniae alba andOlibanum play an important pharmacological effects in the prescription.So weadopts the thin layer identification methods to identify Notopterygium incisumand Gentiana macrophylla.The quality of radix paeoniae alba differences onthe market at present,We increased the content determination method to ensuredrug quality.We formulated the content determination method of Octylacetate,to control the quality of the volatile oil and Olibanum.The study is helpful to improve the quality standard of Jingfukanggranule,to improve the level of overall quality control,and guarantee thestability of drug efficacy.Objective:1. Notopterygium incisum and Gentiana macrophylla in JingfukangGranule were detected and indentified by TLC, and establish theiridentification methods, two kinds of TCM were added to the detection itermsby TLC, so as to controlling the productive process of Jingfukang Granule andprovide a basis for its qualitative identification.2. To establish content determination method of paeoniflorin inJingfukang Granule by using HPLC, and to determin transport rate ofPaeoniflorin from radix paeoniae alba to Jingfukang Granule, so as to laying afoundation for content determination and limitation of paeoniflorin inJingfukang Granule.3. To study content determination method of octyl acetate in JingfukangGranule by using GC, and determin transport rate of Octylacetate fromOlibanum to Jingfukang Granule, so as to laying a foundation for contentdetermination and limitation of octyl acetate in Jingfukang Granule, and tocontrol the contents of volatile oil. Methods:1. Silica gel plate H was used and chloroform-methyl alcohol-ammoniawater (7:2:0.5) as the developing solvent to identify Notopterygium incisum ingranules qualitatively; Silica gel plate GF254was used and chloroform-methylalcohol-water (8:2:0.1) as the developing solvent to identify Gentianamacrophylla in granules qualitatively.2. The content determination of Paeonia lactiflora in gradules wasperformed on a Agilent C18(5μm,4.6mm×250mm) column, chromatographicconditions were determine wavelength:230nm,flow rate:1mL·min-1,columntemperature25℃, sample size10μL.3. Content of octyl acetate in Jingfukang Granule was determined byusing GC, the detector was FID, determination was performed on a HP-5(30m×0.32mm×0.25μm) capillary column. chromatographic conditions wereinjection port temperature:220℃, detector temperature:260℃, carrier gas:nitrogen, flow rate:2mL·min-1, split ratio:20:1. temperature programming wasinitial temperature kept for two minutes, and temperature rise at a rate of10℃per minute until200℃, final temperature kept for10minutes.Results:1. The spots in the TLC were clear and identified without the interferenceof negative control. The Rf of Nodakenin and gentiopicroside wererespectively0.45and0.50in the experiment of Notopterygium incisum andGentiana macrophylla identifications. The identification of Notopterygiumincisum and Gentiana macrophylla was intuitivel and marked by using TLC.2. The content determination method of paeoniflorin in JingfukangGranule was established by HPLC. The linearity range was0.01613~0.4896m g·mL-1, r=0.9999. The average recovery was99.7percents, RSD was1.26percents(n=9). The RSD of repeatability was1.08percents (n＝9). Limit ofdetection was4.938ng. The range of paeoniflorin contents in twelve batches ofJingfukang Granule was1.81~3.47mg/g.3. The content determination method of octyl acetate in JingfukangGranule was established by GC. The linearity range was0.1565～ 7.824mg·mL-1, r＝0.9999.The average recovery was100.00percents，RSDwas1.91percents (n＝9). Limit of detection was1.6336ng. The range ofoctyl acetate contents in seven batches of Jingfukang Granule was0.1803~0.3624mg/g.Conclution:1. Notopterygium incisum and Gentiana macrophylla in JingfukangGranule were identified by TLC, the spots were clear and identifing easily. thismethod was easy, simple, and practical, and it can be identification method ofJingfukang Granule.2. The built content determination method of paeoniflorin in JingfukangGranule by HPLC was highly specific without the interference of negativecontrol. The established method was simple, accurate, and had goodreproducibility. The contents determination method of paeoniflorin was set upby determinating different years and batches Jingfukang Granule, and thismethod can be used as one of quality control means of Jingfukang Granule.3. The built content determination method of octyl acetate in JingfukangGranule by GC was simply, repeatability was good, and without theinterference of negative control. The method can provide a basis for thedetermination of octyl acetate in Jingfukang Granule, and it can also be theway to control the contents of volatile oil in this granules.