Study On Quality Control Standard Of Xianqu Tablets

Objectives: Composed of Opuntia,Monascus and grape seed extract,Xianqu tablet is a natural functional food with cactus as the main raw material,supplemented by red yeast rice and grape seed extract.It has the function of increasing immunity,preventing hyperlipidemia,hypertension,fatty liver and diabetes,and the product has obtained food standard.Currently,considerable studies have been reported that the key point of its quality control is mainly focus on the the detection of amino acids,vitamins,trace elements,and proteins of products,However,we scarely know about systematic studies on the quality standards of raw materials and preparations.In our current work,on the basis of establishing and improving the quality standards of raw materials with cactus,Monascus and grape seed extract,the quality control standards for Xianqu tablets were futher established to provide basis for quality control.Methods: 1.The origin and authenticity of cactus were identified by microscopy and the rutin was identified by thin layer chromatography(TLC),as well as the moisture,ash(including acid-insoluble ash),and heavy metal limits in cactus were checked;the contents of polysaccharides and total flavonoids in cactus were determined by phenol-sulfuric acid method and sodium nitrite-aluminum nitrate-sodium hydroxide method,respectively;the activity of superoxide dismutase(SOD)in cactus was determined by pyrogallol autoxidation method;to draw up the limits of various indicators and draft the protocol quality standard for cactus raw materials.2.To establish and improve quality control standards for raw material extracts of grape seed extract: The catechins in grape seeds was identified by thin layer chromatography(TLC),as well as the moisture,ash(including acid-insoluble ash),and heavy metal concentrations in the raw materials of grape seed extract were examined;the contents of polyphenols and procyanidins were determined using the Folin-Phenol and n-Butanol-Hydrochloric acid methods,respectively;the limits of various indicators were formulated and the draft quality standards for the drug substance of the grape seed extract were drafted.3.To establish and improve quality control standards for Monascus raw materials: the origin and authenticity of Monascus were identified by microscopy and the lovastatin was identified by high performance liquid chromatography(HPLC);the moisture,ash content(including acid insoluble ash)and heavy metal contents of the red yeast rice were determined;the HPLC method was used to determine the amount of ring-opening(ie,acid)and closed-loop(ie,ester)lovastatin in Monascus;the limits of various indicators were established and the draft quality standard of Monascus raw materials was drafted.4.To e stablish the quality standard of Xianqu tablets: Rutin and catechins,which were index components of Xianqu tablets,were determined by TLC;Monacolin k in Xianqu tablets was identified by using HPLC method simultaneously;the weight difference,disintegration time limit,and heavy metals of the tablet were measured.The contents of Monacolin k and procyanidins in Xianqu tablets were determined by HPLC and colorimetry,respectively;the limits of various indicators were formulated and the draft quality standards for the drug substance of the Monascus were drafted.Results: The quality control standards for cactus,grape seed extract and Monascus crude drug were established and improved respectively.The quality standard of Xianqu tablets was established.At the same time,the draft quality standards for three raw drugs and preparations of Xianqu tablets were drafted.Conclusion: In this paper,the quality control of the three raw materials of cactus,grape seed extract and Monascus and Xianqu tablets preparation were established by conventional microscopic,TLC,HPLC and UV methods.The method is simple and accurate,and can be used as the basis for quality control of Xianqu tablets.