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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 introduce the application of osmometry in the 2010 edition of Chinese Pharmacopoeia. Methods According to the provisions of General Rules of Injectables in Appendix II of Chinese Pharmacopoeia 2010 edition, the osmolality of test solution was determined by osmolality determination. Results osmolality can lead to hemolysis. If the injection osmotic pressure is too high or too low, intramuscular injection can also produce irritation, and affect the absorption. Conclusion Injection and eye drops in the preparation process according to the situation, in the prescription with different uses of additives and pH regulator, control the osmotic pressure, can effectively control the amount of regulator, especially the amount of pH regulator added. Control of osmotic pressure, can improve the safety of pharmaceutical preparations, regulate the production of pharmaceutical preparations.