Herba sarcandrae is the dry whole grass of the Sarcandra glabra, which is a sort ofchloranthus family plant. Herba sarcandra tastes bitterly but mildly,which clears heat andtoxic material out of the blood, invigorates the circulation of plaque reproduction and hasbeen used to cure the disease like the purpura, rheumatism and injuries from falls, fractures,contusions and strains.Even though the injection of herba sarcandrae has been widely used in the clinicsituation as an emergent medicine, the problem of being unable to keep the injection stable isthe bottleneck to restrict it from further development. Therefore the main goal of thedissertation is to realize the way to manufacture a sort of stable lyophilized powder of theherba sarcandrae that solves the problem of stability for further application of the herbal.The dissertation investigated different kinds of excipients and their quantities to be addedto each concentration of lyophilized powder so as to check out their impacts in the process oflyophilized powder manufacturing. By finding out the eutectic point and the optimaltechnological parameters, the dissertation finished the manufacturing process. According tothe2010Chinese pharmacopoeia standards, the dissertation inspected several characters ofthe lyophilized powder to make sure the technology that makes the products meet the basicquality requirement.By comparing with the standard isofraxidin solvent, the total amount of coumarin in thelyophilized powder could be determined by the absorbance of ultraviolet spectro-photometryand in contrast to fumeric acid, the total content of organic acids could be judged by thepotentiometric method of acid and base titration. Through the method of HPLC, the contentsof isofraxidin and fumeric acid were ensured in the standard curves drawn by differentconcentrations of standard solvent. By making sure the amounts of the chemicals above, thedissertation finished the evaluations of the product quality control.Apart from these, due to the accelerated stability test and the highlight exposureexperiment could the dissertation accomplish the stability evaluations to the product. |