蚓激酶肠溶胶囊耐酸力测定方法研究

Determination of acidresistivity of lumbrokinase enteric-coated capsules

目的:建立并验证蚓激酶肠溶胶囊耐酸力测定方法。方法:采用效价测定法,探索蚓激酶肠溶胶囊耐酸力测定方法的供试品溶液制备条件(微丸溶剂、超声时间、静置时间),并通过分析方法学验证耐酸力测定方法的可行性。结果:微丸溶剂选择磷酸盐缓冲液(p H 6.8)为宜,微丸溶解超声时间为3 min,微丸溶解液的静置时间为10 min;耐酸力测定方法的加样回收率为99.16%;精密度RSD为1.13%;重现性RSD为1.02%;空白微丸和肠溶包衣材料的加入对耐酸力测定无明显影响;微丸溶解液在室温下存放24 h内测定耐酸力无明显影响。结论:蚓激酶肠溶胶囊耐酸力方法的准确度、精密度、重现性、专属性和耐用性均良好,方法学研究符合规定。耐酸力测定方法可用于对蚓激酶肠溶胶囊的耐酸性能检控。

Objective： To establish and validate the method for the determination of acidresistivity of lumbrokinase enteric-coated capsules . Methods： The preparation conditions of the test solution for lumbrokinase enteric- coated capsules for acidresistivity test were explored in the term of pellets solvent, ultrasonic time, and static time, by the titer determination method. In addition, the feasibility of acidresistivity testing method was confirmed by the analytical methods. Results ： Micro pill solvent selection of phosphate buffer solution （ pH 6.8 ）was appropriate, micro pill ultrasonic dissolving time was 3 min, micro pill solution standing time was 10 min; acid method for the determination of recovery rate was 99.16%; RSD was 1.13%; the reproduced RSD was 1.02%; blank micro pill and enteric coating material added exhibited no significant effect on resistance to acid content; there was no significant effect of micro pill solution at room temperature stored within 24 hours on the determination of resistance to acid. Conclusion： The results demonstrate the accuracy, precision, repeatability, specificity and durability of the acidresistivity test, which coincides with provisions of analytical methods. Furthermore,the acidresistivity tests proved to be efficient for determination of acidresistivity of lumbrokinase enteric-coated capsules.