目的：制备盐酸普拉克索缓释微丸胶囊，建立其有关物质的检测方法。方法：采用流化床空气悬浮包衣法制备载药丸芯，以乙基纤维素水分散体（Surelease®）进行包衣，制成盐酸普拉克索缓释微丸，装入胶囊即可。采用高效液相色谱（HPLC）法检测缓释微丸中有关物质，色谱柱为Capcell PAK MG-ⅡC18（150 mm×4.6 mm，5μm）；梯度洗脱，流动相A为甲酸铵缓冲液（pH 5.0），流动相B为甲醇；流速为1.0 ml/min；二极管阵列检测器，检测波长为240、262、326 nm；进样量为80μl。结果：该色谱条件下，盐酸普拉克索能与7种有关物质完全分离，且空白辅料不干扰测定，7种有关物质检测质量浓度的线性范围均为0.2～2μg/ml（r＞0.9990），检测限为0.5～1.8 ng，定量限为1.7～5.9 ng，平均回收率为98.93％～102.0％（RSD为1.90％～0.24％，n＝9），精密度和稳定性试验的RSD均小于1.0％（n＝5）。所制得的盐酸普拉克索缓释微丸胶囊中仅检测出1种有关物质。结论：成功制得盐酸普拉克索缓释微丸胶囊；所建立的HPLC法可用于其有关物质的检测。%OBJECTIVE:To prepare Pramipexole dihydrochloride sustained-release pellets capsules and to establish a method for the determination of related substances. METHODS:Drug loaded core was prepared by fluid bed air suspension coating meth-od,and pramipexole dihydrochloride pellets were prepared using Surelease® as coating materials and put into capsules. HPLC meth-od was used to determine related substance in sustained-release pellets;the determination was performed on Capcell PAK MG-ⅡC18 column(150 mm×4.6 mm,5 μm)with mobile phase A consisted of ammonium formate buffer solution(pH 5.0)and mobile phase B consisted of methanol for gradient elution at flow rate of 1.0 ml/min;diode array detector was used with detection wave-length of 240,262,326 nm and injection volume of 80 μl. RESULTS:Pramipexole dihydrochloride and 7 kinds of related sub-stances were separated by the established HPLC conditions. The blank excipient did not interfere with the assay of the related sub-stances. The linear ranges of 7 related substances were 0.2-2 μg/ml(r>0.999 0);the limit of detection ranged 0.5-1.8 ng,and the limit of quantitation ranged 1.7-5.9 ng;average recovery ranged 98.93%-102.0%(RSD were 1.90%-0.24%,n=9). RSD of preci-sion and stability test were all lower than 1.0%(n=5). Only one related substance was found in prepared Pramipexole dihydrochlo-ride pellets capsules. CONCLUSIONS:Pramipexole dihydrochloride pellets capsules are prepared successfully. Established HPLC method can be used for the determination of its related substances.
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