Establishment of Quality Control Method in Production of Jinshuibao Capsules / 中国实验方剂学杂志

ABSTRACT

Objective:To improve the quality control system in the production of Jinshuibao capsules, and to provide experimental basis for the follow-up research and application of this preparation. Method:High performance liquid chromatography (HPLC) was employed, the analysis was performed on a Ultimate AQ-C18 column (4.6 mm×150 mm, 5 μm). The chromatographic conditions for the determination of adenosine, guanosine and uridine were as following mobile phase of methanol-0.1%formic acid aqueous solution for gradient elution, the flow rate of 0.4 mL·min-1, column temperature at 30 ℃, sample quantity of 10 μL, detection wavelength at 260 nm. The chromatographic conditions for the determination of ergosterol were as follows mobile phase of methanol-water (98∶2), the flow rate of 1 mL·min-1, column temperature at 25 ℃, sample quantity of 10 μL, detection wavelength at 283 nm. Result:The main chromatographic peaks of fermented Cordyceps powder samples in different production stages showed little difference. The linear relationships of adenosine, guanosine and uridine were good (R2 >0.999), their recoveries were 106.06%, 101.25%and 105.88%, respectively. The contents of adenosine and ergosterol in 20 batches of samples extracted from 2016 to 2018 were in line with the requirements in the 2015 edition of Chinese Pharmacopoeia, the contents of guanosine and uridine were 0.97-1.36, 0.67-1.38 mg/capsule, respectively. Conclusion:The quality of Jinshuibao capsules in the market is stable. This method can be used to detect the quality of Jinshuibao capsules, and it is simple, stable and reliable.