Studies On Preparation And Quality Standards Of Licorice Anti-thrombotic Dropping Pills

Objective:1) To extract and purify licorice anti-thrombotic effective components, meet the requirements of new medicines registration with the total effective components more than 50%.2) Ensuring the optimum preparation process and quality standard of the Licorice Anti-thrombotic dropping pills, for providing the research data application for pre-clinical studies. Methods:1) We established a method for determination of liquiritin and glycyrrhizic acid content in Licorice Anti-thrombotic Dropping Pills (LADP) by HPLC.2) We used the orthogonal design to arrange the experiment at the base of the single factor experiment's foundation.3) We established the quality standards of LADP according to China pharmacopoeia 2005 edition I, item under Pills. Results:1) the optimal extraction conditions of the effective components:water was as extractive solvent, the ration of solid material to liquid is 1:12, extraction temperature is 80℃, the extraction time is 4h(2h,1h,1h), Incorporating three times the filtrate,concentrated to 5 times of volume.2) Use AB-8 Macroporous resin to purify the effective components of licorice anti-thrombotic part.purification techniques:licorice anti-thrombotic part extracts to 0.2g/ml of the sample concentration,3 BV/h of the adsorption rate. Washed with 3BV water,then use 4BV 30% ethanol to 3 BV/h rate for elution;the content of the effective components was reached 63.19% and satisfied the request of new medicine registration.3) Preparation technique of Licorice Anti-thrombotic dripping pills:The optimum dropping condition was as follows:the condensing agent was dimethyl silicone oil and gradient condensing temperature was 20～15℃,15～10℃,10-3℃, the temperature of extracted liquid was 90℃, dripping distance was 8 cm,diameter and outer diameter of the dropper was 2.5/3.0 mm and dripping speed was 35 drops per minute. the optimum formulation was medicinal powder:(PEG6000:PEG4000)=1:2.5(1.3:1).4) Determination of Licorice Antithrombotic dropping pills:The content of glycyrrhizic acid and liquiritin were 152.51mg/g and 40.40mg/g. Weight and dissolution time of dropping pills were 45.4mg and 9.5min. Conclusion:1) Experimental results show that the extraction and the purification of the effective components of Licorice Anti-thrombotic part and preparation method of Licorice Anti-thrombotic driopping pills are reasonable and feasible.2) The determination method of Licorice Anti-thrombotic dropping pills is feasible and specific.