药品标准规定某些制剂向 pH 值范围以增加其稳定性,减小对机体的刺激,加速对药物的吸收。在一定程度上 pH 值反映了制剂内在质量,是制剂检测中一个重要项目。有的医院认为人体对酸硷耐受范围较宽,pH 值高一点低一点关系不大。检测制剂往往注重含量、澄明度和热原,较易忽略pH 值,以致有因注射液 pH 值过低引起伤口组织坏死的事故发生。我们检测制剂半成品重视了 pH 值变化情况,从而能发现问题,及时处理,保证了质量。现将5批pH 值异常的制剂半成品处理情况报告如下。例一,配制26万毫升5％葡萄糖注射液,含量合格,pH3.0较历来均值低1.16,也低于中国药典77年版(简称“药典”)规 Drug standards require certain formulations to increase the pH range to increase their stability, reduce the body’s stimuli, and accelerate the absorption of drugs. To a certain extent, the pH reflects the intrinsic quality of the preparation and is an important item in the preparation testing. Some hospitals believe that the human body to a wide range of pH tolerance, pH value a little lower little relationship. Test preparations tend to focus on content, clarity and pyrogen, easier to ignore the pH, resulting in injection pH value is too low cause wound tissue necrosis accident. Our testing of semi-finished products focused on pH changes, which can identify problems, timely processing, to ensure the quality. Now five batches of pH abnormalities in the preparation of semi-finished products are reported below. For example, 260,000 ml of 5% dextrose injection was prepared and the content was acceptable. The pH value was lower than the historical average of 1.16 by a factor of 1.16 and also lower than the 77th edition of the Chinese Pharmacopoeia (“Pharmacopoeia”)