小儿解热中空栓的制备及体外溶出度研究

Preparation of Xiao' er Jiere Hollow Type Suppository and Its in-vitro Dissolution

目的制备小儿解热中空栓并建立其溶出度的测定方法。方法制备小儿解热中空栓,并采用体外溶出度试验和HPLC法,以黄芩苷和绿原酸为对照,考察普通栓和中空栓中黄芩苷和绿原酸的累积溶出度。结果黄芩苷在0.040μg～0.320μg范围,绿原酸在0.064μg～0.512μg范围线性关系良好,中空栓在30min时释药累积溶出量可达97%以上。结论中空栓比普通栓释药速度快。该试验方法稳定可靠,结果准确。

Objective To establish the preparation method of Xiao＇ er Jiere hollow type suppository and determination method of the dissolubility. Methods Xiao＇ er Jiere hollow type suppository and ordinary suppository were prepared. With bacalin and chlorogenic acid as the standards, the in - vitro dissolution test and HPLC method were applied to determine the accumulated dissolution rate of bacalin and chlorogenic acid in two different types of suppository. Results The linearity of bacalin was in the range of 0. 040 μg - 0. 320 μg（ r = 0. 999 7） and that of chlorogenic acid was in the range of 0. 064- 0. 512 μg（ r = 0. 999 8）. The accumulated dissolution rate of the hollow type suppository was over 97 % in 30min. Conclusion Drug release rate of hollow type suppository is higher than the ordinary suppository. The method is stable and accurate.