Preparation and Quality Evaluation of Jinlei Capsule / 中国药房

ABSTRACT

OBJECTIVE： To prepare Jinlei capsule and evaluate its quality. METHODS： Wet granulation was adopted. The molding technology of Jinlei capsule content granule was optimized with drug-excipient ratio， excipient ratio and ethanol volume fraction as factors， using comprehensive score of particle forming rate， moisture content and fluidity as the evaluation index. According to 2015 edition of Chinese Pharmacopoeia （part Ⅳ）， the characters， moisture， volume difference， disintegration time limit were checked. Qualitative identification of Gentianopsis paludosa and Lysimachia christinale were analysed by TLC， and quantitative analysis of luteolin and kaempferol were analysed by HPLC. RESULTS： The optimal molding technology of Jinlei capsule content granule was that the maltodextrin and the micro-silica gel are mixed as a mixed auxiliary material according to 10 ∶ 1 and then mixed with the drug powder by 1 ∶ 0.5， using the wet granulation method with 90％ ethanol as wetting agent. The characters， moisture， volume difference and disintegration time limit of Jinlei capsule were in line with Chinese Pharmacopoeia. TLC showed the same color spots on the corresponding positions of the reference chromatogram. The linear range of luteolin and kaempferol were 4.4-88.0 μg/mL and 9.6-96.0 μg/mL （all r＝0.999 9）. RSD of precision （n＝6）， reproducibility （n＝6） and stability （18 h， n＝7） tests were all lower than 2.5％. The average recoveries were 95.74％ and 99.77％ （RSD＝1.50％， 2.72％， n＝6）； the content of them were 2.52， 0.34 mg/g. CONCLUSIONS： The optimal molding technology of Jinlei capsule is stable and feasible； prepared Jinlei capsule in controllable in quality.