The Study of Quality Standards and Determination of Validity Period of Awei Capsules

Objective:In order to use the drug safely and effectively,we establish the quality standards and predict the validity period of A Wei Capsules. Methods:①Rhizoma Bistortae、Cortex Magnoliae Officinalis, Rhizoma Imperatae were identified by Thin Layer Chromatograph;②The contents of Gallic Acid、Magnolol and Honokiol were determined by High Performance Liquid Chromatograph.③Put the sample in different humidity、examine the level of absorbing water and get critical relative humidity.④Classical constant temperature test:put capsules at different temperature of 80℃、90℃100℃,examine sample at different time, the change of different indexes content at different time was determined to estimate the validity period of the capsules.⑤According the items of China Pharmacopoeia,we determine the content of water、loaded quantity differences、crumbling time limit and microbial limits. Results:①Rhizoma Bistortae、Cortex Magnoliae Officinalis、Rhizoma Imperatae have same colour spots on the same location according the reference substance and the negative samples have no interference.②Determined by High Performance Liquid Chromatograph,the content of GallicAcid was 1.081±0.064mg/g, The contents of Magnolol and Honokiol were respectively 14.56±0.058mg/g、6.15±0.036mg/g.③The critical relative humidity was 72%,It presented that we should control surroundings humidity under72% when producing and storaging drug.④he activate energies of different indexes was calculated based on Arrhinius formula and the validity period was predicted 2.75 years for Magnolol,1.77 years for Honokiol.⑤We should control the content of water was under 7%, the methods of crumbling time limit were adding 700ml water at 37℃,loaded quantity differences and microbial limits were done by the methods of China Pharmacopoeia.Conclusion:Through multicomponent andmulti-index, Establis h the standard of A Wei Capsules. We can predict the validity period of capsules with the index of contents. All of these can provide the experiment evidence of evaluating drug quality and storage times.