31批复方甘草口服溶液的质量考察

Investigation of Quality of 31 Batches of Compound Glycyrrhiza Oral Solutions

目的:考察31批不同厂家复方甘草口服溶液的内在质量。方法:采用高效液相色谱法测定复方甘草口服溶液中吗啡和愈创甘油醚的含量,并检测溶液的pH值。结果:31批复方甘草口服溶液中有13批的吗啡含量不合格,1批愈创甘油醚含量不合格,1批pH值不合格。结论:有关厂家应严格按照《中国药典》相关规定控制产品的内在质量,以保证临床用药安全、有效。

OBJECTIVE： To investigate the internal quality of 31 batches of Compound Glycyrrhiza oral solutions from different manufacturers. METHODS： The contents of Morphine and Guaifenesin in Compound Glycyrrhiza oral solutions were determined by HPLC, and the pH value of the solution was detected as well. RESULTS： Of the total 31 batches of samples, 13 was unqualified in Morphine content, i was unqualified in Guaifenesin content, and 1 was unqualified in pH value. CONCLUSION： The manufacturers should strictly obey the standards recorded in China Pharmacopoeia in respect of quality control to ensure the safety and efficacy of clinical medication.