对22个已上市中药大生产中醇沉上清液的实际含醇量情况进行了调研。调研结果显示, 中药醇沉的实际含醇量普遍高于质量标准规定的目标含醇量。同品种不同批次之间的醇沉含醇量也存在一定差异。实际醇沉含醇量与目标含醇量之差可能与具体品种、企业醇沉加醇量的确定方法及具体操作等有关。对调研结果进行了分析并提出建议:(1)对中药质量标准"制法"项下规定的醇沉目标含醇量的含义进行明确解释, 统一认识;(2)应明确中药新药醇沉加醇量的确定方法及在线控制指标;(3)在工艺验证时用药典法测定醇沉上清液的实际含醇量, 确认按确定的方法生产能否使醇沉实际含醇量达到预期目标;(4)中药新药的醇沉工艺应进行系统研究, 并在"生产现场检查生产工艺"中明确醇沉加醇量的确定方法等。

The data of the alcohol concentration in alcohol precipitation process of 22 Chinese materia medica (CMM) were investigated and analyzed. The result showed that the real alcohol concentration in the alcohol precipitation process was higher than the expected generally, and the real alcohol concentration in the alcohol precipitation process in the same product was different in different batches. The gap between the real alcohol concentration in the alcohol precipitation process and the expected maybe related to the product and the method to determine how much alcohol to be added and the way of operation. The data above were analyzed, and some suggestions were presented as follows: (1) Meaning of the expected alcohol concentration in the alcohol precipitation process described in the drug quality specification should be explained clearly; (2) The method used to determine how much alcohol should be added and the indicator of on-line control should be studied and determined; (3) During the process validation, the real alcohol concentration in the alcohol precipitation process should be detected according to the procedure in China Pharmacopeia (2010 edition) and make sure whether the real alcohol concentration in the alcohol precipitation process was the same as the expected; (4) The alcohol precipitation process of new CMM should be systematically studied, and the method used to determine how much alcohol should be added must be on record in ‘Production Process for Oon-site Inspection’.