Study on Preparation Technology and Quality Control of Sinomenine Hydrochloride Dripping Pills

OBJECTIVE To optimize preparation technology and to establish a method for quality control of sinomenine hydrochloride dripping pills. METHODS Orthogonal test was applied to optimize the preparation with the choice of the drug temperature, the proportion of two substrates (PEG4000∶PEG6000), the proportion of substrate to drug, and dropping speed. Sinomenine hydrochloride in dripping pills was determined by HPLC. RESULTS The optimum preparation was as follows, drug solution temperature 75 ℃, the ratio of PEG4000 to PEG6000 (1∶4 ) and drug to substrate (1∶3). Dimethicone was refrigerant with 60 dropping per minute. For sinomenine hydrochloride, the linear range was 0.2-1.0 μg·mL^-1(r=0.999 5), and the average recovery was 99.3%, RSD was 1.2%. CONCLUSION The pills can be produced through this process with the simple and reliable method. The determination method is simple, specific, reproducible and accurate, which can be applied to the quality control for the sinomenine hydrochloride dripping pills.