Research On Quality Control Methods Of Duzhong Jiangya Tablet

The Duzhong Jiangya Tablet consists of 5 medical materials which are Eucommiae Cortex,Leonuri Herba,Prunellae Spica,Scutellariae Radix and Uncariae Ramulus Cum Uncis.The earliest record was found in ChP 1977,It contains the standard of the tablet which only has the microscopic identification and physiochemical identification of Uncariae Ramulus Cum Uncis,hasn't determination of content.In 1992,it is the sixth Volume of the Ministry of health drug standards,the standard number is WS3-B-1185-92.The name was changed to Compound cortex eucommiae piede(Duzhong Jiangya Tablet),the prescription was same as ChP 1977 but the preparation was changed.In this standard,only has the microscopic identification and physiochemical identification of Uncariae Ramulus Cum Uncis,hasn't determination of content.Guangzhou Xiangxue pharmaceutical incorporated company had modify the dosage form in 2014,the national drug standard number is YBZ28882005(WS3-B-1185-92-1),which only has the microscopic identification and physiochemical identification of Uncariae Ramulus Cum Uncis,hasn't determination of content.Kangpu pharmaceutical incorporated company to improve the drug standards in 2015.Standard of State food and drug administration YBZ07792004(WS3-B-1185-92-2)which has the TLC methods of Leonuri Herba and Prunellae Spica and determination of content of Scutellariae Radix.The Duzhong Jiangya Tablet has the efficacy of tonifying kidney,calming the liver,clearing heat.Apply to the hypertension disease of flourishing of liver or insufficieney of kidney.At present,it is less report on quality control methods about Duzhong Jiangya Tablet.Therefore it is important to establish the quality control method.Eucommiae Cortex to tonify the liver and the kidney,to strengthen the tendons and bones,and prevent miscarriage.Leonuri Herba menstrual disordera,dysmenorrheal,amenorrhea,incessant,drippling of lochia;edema and oliguria such as edema in acute nephritis.Prunellae Spica inflammation of the eyes,ophthalmalgia at night,headache and dizziness;scrofula,goiter,mastitis with swelling and pain,hyperplasia of breast;hypertension.Scutellariae Radix oppressed feeling in the chest,nausea and vomiting in epidemic febrile diseases caused by damp-heat or summer-heat;feeling of stuffiness in the abdomen,acute dysentery or jaundice caused by damp-heat;cough due to heat in the lung;high fever with dire thirst;spitting of blood and epistaxis due to heat in blood;carbuncles and sores;threatened abortion.Uncariae Ramulus Cum Uncis headache dizziness,convulsion,eclampsia,hypertension.This study established TLC methods of Eucommiae Cortex,Leonuri Herba and Uncariae Ramulus Cum Uncis,HPLC method for Rosmarinic acid of the Prunellae Spica and Baicalin and Baicalein of the Scutellariae Radix in Duzhong Jiangya Tablet,established the specific chromatogram of Duzhong Jiangya Tablet.Objective: To establish the quality control methods of Duzhong Jiangya Tablet.Methods: The Eucommiae Cortex,Leonuri Herba and Uncariae Ramulus Cum Uncis were indentified by TLC and Rosmarinic acid,Baicalin and Baicalein were simultaneous determined by HPLC.The fingerprint research method of Resina Draconis was also by HPLC,which the chromatographic column was Thermo Fisher C18(4.6 × 250mm;5?m),the mobile phase was acetonitrile-0.1% phosphoric acid solution with gradient elution,flow rate was 1.0 mL·min-1,the detection wavelength was 330 nm,the column temperature was 30?.Results: The TLC identification exhibited same colour spots on the same location with control solution.The specific chromatogram research method of Duzhong Jiangya Tablet was established,which are Eucommiae Cortex,Leonuri Herba,Prunellae Spica,Scutellariae Radix and Uncariae Ramulus Cum Uncis.The RRT of 8 characteristic peaks were 0.37?0.48?0.51?0.59?0.95?1.00?1.40?1.46,respectively.On the research of assay,Rosmarinic acid showed a good linear relationship in the range of 49.9~898.6?g,the regression equation was Y=3086.1x+2607.1,R2=1.Baicalin showed a good linear relationship in the range of 0355.2~6776.0?g,the regression equation was Y=1656.8x-145198,R2= 0.9996.Baicalein showed a good linear relationship in the range of 83.5~453.6?g,the regression equation was Y=2827.8x-24929,R2= 0.9998.The precision,repeatability and stability of the method were satisfying.The average recoveries of rosmarinic acid,baicalin and baicalein were 101.7%,98.1%and 97.6%,respectively,RSD<2%.Conclusion: The methods established in this study with good specificity which can be used to control the quality of the product.