Investigation of alcohol concentration in alcohol precipitation process in compound preparation of Chinese materia medica / 中草药

ABSTRACT

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'.