Through comprehensive evaluation and analysis of the quality of Liuwei Dihuang (LWDH) preparations from different manufacturers and combining factors such as productiontechnology, the key factors in the quality control of LWDH preparations are explored to provide a reference for improving the quality control level of LWDH preparations.
Method:
Morroniside, loganin and paeonol as quality control markers of LWDH products were determined by high performance liquid chromatography (HPLC), the mobile phase was acetonitrile (A) -0.3% phosphoric acid aqueous solution (B) for gradient elution (0-5 min, 5%-8%A; 5-20 min, 8%A; 20-35 min, 8%-20%A; 35-45 min, 20%-60%A; 45-55 min, 60%A), the detection wavelength of paeonol was at 274 nm, and the detection wavelengths of morroniside and loganin were at 240 nm. The quality characteristics of LWDH preparations with different dosage forms (big candied pills, water-honeyed pills, concentrated pills, hard capsules and soft capsules) from different manufacturers were analyzed. Combined these results with their actual production processes, the key-points of quality control in the whole production process were discussed.
Result:
The contents of three index ingredients in 128 batches of LWDH preparations were all in conformity with the standards of the 2015 edition of <italic>Chinese Pharmacopoeia</italic>, however, the content limit of some dosage forms in the current standard was unreasonable. For example, although the daily dose of crude drugs for big candied pills were almost twice the dose of water- honeyed pills (15.00, 8.57 g, respectively), they got exactly the same daily limits of the contents for both the quality markers. What′s more, these two formulations had the same process, so the differences between the process obviously could not be the reason of these differences.