渗透压测定法在药品检验中的应用

Application of Determination of Osmolality in Drug Control

目的介绍渗透压测定法在中国药典2010年版中的应用情况。方法依照中国药典2010年版二部附录IB注射剂通则项的规定,采用渗透压摩尔浓度测定法,测定供试液的渗透压摩尔浓度。结果渗透压过低能导致溶血。如果注射液渗透压过高或过低时,肌肉注射也能产生刺激性,且影响吸收。结论注射剂和滴眼剂在配制过程中要根据情况,在处方中加有不同用途的添加剂和pH调节剂,控制渗透压,可以有效控制调节剂的加入量,尤其是pH调节剂的加入量。控制渗透压,能够提高药物制剂安全性,规范药品制剂生产。

Objective To describe the application of determination of osmolality in the Chinese Pharmacopoeia 2010 edition. Methods According to the stipulation of Chinese Pharmacopoeia 2010 edition. Adopt osmolatily concentration determination method. Results Most of the eye drops and intravenous fluids increase osmotic pressure control. Osmotic pressure is too low can lead to hemolysis. If the osmotic pressure is too high or too low in injection, the intramuscular injection can produce irritation, and impact absorption. Conclusion Injection and eye drops in the preparation process according to the situation in prescription use, osmotic pressure control can effectively control the dosage of regulators, especially the pH adjusting agent dosage. Control the osmotic pressure, can improve the safety of pharmaceutical preparations, production of pharmaceutical preparations.