Study on the Dissolution of Xiaocaihu Pill from Different Manufacturers

VernacularTitle:不同厂家小柴胡汤丸的溶出度研究
Author: Fushan TANG ; Xiaohui ZHANG ; Xue LAN ; Cui MENG ; Yuhe WANG
Publication Type:Journal Article
Keywords: Xiaochaihu pill; Baicalin; Dissolution
From: China Pharmacy 2016;27(30):4272-4274
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To establish a method for the determination of dissolution of Xiaocaihu pill,and compare the differ-ence of preparation from different manufacturers. METHODS:Using 0.1 mol/L HCl as dissolution medium,rotating basket method was used to determine the dissolution of preparations. HPLC was adopted to determine the content of baicalin:column was TSKgel ODS C18 with mobile phase of methanol-water-phosphoric acid (65∶35∶0.7,V/V/V) at a flow rate of 1 ml/min,detection wave-length was 280 nm,column temperature was 30 ℃,and injection volume was 5 μl. RESULTS:The linear range of baicalin was 0.488-124.8 mg/L (r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 2.0%;recovery was 100.14%-104.78%(RSD=1.58%,n=9). The average t50(50% dissolution time)of baicalin was 85.81 min. CONCLUSIONS:The method is simple with good precision,stability and reproducibility,and can be used for the dissolution determination of Xiaocaihu pill. Xiaocaihu pill from different manufacturers shows great differences,both preparation formulation and clinical use should attach importance to the dissolution of solid preparations.