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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 verify the determination of acid resistance of lumbrokinase enteric-coated capsules. Methods: To determine the preparation conditions (pellet solvent, ultrasonic time, standing time) of the test method for the determination of acid resistance of lumbrokinase enteric-coated capsules by the method of titer determination, and to verify the feasibility of the acid resistance determination method by analytical methodology Sex. Results: The best choice of phosphate buffer (p H 6.8) for pellet was solvent, the time for ultrasonic dissolution of pellets was 3 min, the time for pellet dissolution was 10 min, and the recovery rate of acid resistance was 99.16 %; RSD of precision was 1.13%; RSD of reproducibility was 1.02%; addition of blank pellets and enteric coating material had no significant effect on acid resistance; pellet lysis solution was stored at room temperature within 24 h, Clearly affected. CONCLUSION: The accuracy, precision, reproducibility, specificity and durability of lumbrokinase enteric-coated capsules are good, and the methodological study is in accordance with the regulations. Acid resistance determination method can be used for the acid resistance of lumbrokinase enteric-coated capsules prosecution.