Studies On The Quality Controlling Method Of Functional Health Products Yier Kang Capsule

Yier Kang Capsule is made of ginkgo biloba extract, polygonum, medlar, polyphenols and xylitol, and has immune function, especially anti-aging. In this thesis, the TLC method and HPLC method were established for related components distinguishing and measurement, while a preliminary study also conducted on the determination of trace elements. The result improved Yier Kang capsule quality control methods and provides a reasonable basis for clinical application. Content as below:1. Yier Kang Capsule Introduction and advances in spectroscopy applications of HPLC and atomic absorption in pharmaceutical analysis.2. TLC methodsEstablish methods of identification of Ginkgo biloba extract; With TLC method, sodium carboxymethyl cellulose solution containing0.4%sodium acetate as a binder G plates, ethyl acetate-butanone-formic acid-water (5:3:1:1V/V) as the developing solvent,3%ethanol solution of aluminum trichloride to develop, View under365nm UV lamp; Results showed that in the test sample’s chromatograph, same color bright green fluorescent spots showed at the relevant position of the Ginkgo biloba extract at Rf=0.72.Established identification methods of polyphenols:With TLC, using sodium carboxymethyl cellulose as a binder of H plates, chloroform-methanol (7:3V/V) as the developing solvent, dry, then chloroform-methanol (20:1V/V) as the developing solvent, view under UV lamp365nm. The results showed that in the test sample’s chromatograph, same color bright blue fluorescent spots showed at the relevant position of the Ginkgo biloba extract at Rf=0.15.Established identification methods of medlar:With TLC, using silica gel G plates, ethyl acetate-chloroform-formic acid (3:2:1V/V) as developing solvent, view under365nm UV light. The results showed that in the test sample’s chromatograph, same color bright blue fluorescent spots showed at the relevant position of the Ginkgo biloba extract at Rf=0.68.3. Established HPLC of Yier Kang capsules Ginkgo biloba extract content.Using Kromasil C18column (250mm×4.6mm,5μ m), mobile phase was methanol-0.4%phosphoric acid (52:48) at a flow rate of1.0mL/min, the detection wavelength was360run. The results showed that quercetin, kaempferol and isorhamnetin concentrations had good linear relationship with the peak area in the range of0.165～0.825μg/mL, the0.114～0.570μg/mL and0.042～0.210μg/mL, average recovery rate (n=9) were99.78%(RSD=0.3%),98.96%(RSD=0.32%) and98.22%(RSD=0.50%). The average content of Yier Kang Capsule Ginkgo biloba extract brass was8.0mg/100g.4. Established atomic absorption spectrometry method to determine the content of Mn, Mg, Fe, Cu, Zn, and other five kinds of trace elements in Yier Kang capsulesThe samples were digested using high-pressure tank, the pre-conditions were optimized by the spectrum of each trace elements by flame atomic absorption.5elements of quantitative restrictions were within3.55-53.74μg/mL range with good linear relationship, the correlation coefficient was0.9995-1.0000, recovery was between94.5%and99.9%. The result is6μg/g,400μg/g,140μg/g,2μg/g,1.6μg/g respectively and the method is accurate, fast, simple, reliable, and provides methods for the Yier Kang capsules five kinds of trace elements determination.5. Established graphite furnace methods to determine the content of Pb, Cr in Yier Kang capsules. The samples were digested using high-pressure tank, through the pre-conditions for the spectrum of each experimental optimization of heavy metals by graphite furnace atomic absorption. Quantitative limits of three kinds of heavy metals were within range of0.25～0.74ng/mL, a good linear relationship, correlation coefficient was between0.9994to0.9998recovery rate was between94.6to95.3%. The two element result is0.017μg/g and0.065μg/g.Established hydrides element method to determine the content of As, Hg in Yier Kang capsules. Using high-pressure tank, through preliminary experiments so that all the elements of heavy metal hydride generator working conditions are optimized. Quantitative two kinds of heavy metals limits were between0.02～0.03ng/mL, the correlation coefficient was0.9938～0.9998, good linearity, recoveries were97.5%. The content of As, Hg is0.0165μg/g. The above method is accurate, specific, as measured Yier Kang Capsule heavy metals content approach.