Research On Preparation And Quality Re-evaluation Of Rhizoma Dioscoreae Nipponicae Injection

Objective To explore the reasons for the irritation of the Dioscoreainjection, and optimize the preparation of the Dioscore injection, reducingits irritating and improve the content of its active ingredients, and toestablish the fingerprint of medicinal herbs and preparations of Dioscoreapreparations for quality control.Methods: Muscle irritation test was used as an indicator to investigate thecause of Dioscorea injection irritating; By orthogonal test, the waterextraction of Dioscorea is screened; Using Macroporous resin refinedwater-soluble saponins of Dioscorea, to find the best preparation,determined by the refined extract part of the water-soluble saponins; HPLCmethod was used to establish water-soluble saponin content of Dioscorea,fingerprint determination methods of medicinal herbs and preparationsResults The tannin, the active ingredient itself and PH of the Dioscoreainjection are the reasons for ite irritating. The extraction and refiningparameters of the preparation wae established.To develop the Central Plainsdiosgenin, Dioscorea water-soluble saponin and methyl protodioscin thedetermination of standards HPLC fingerprint of medicinal herbs and theirpreparation of the Dioscorea wae established. Conclusion After the preparation process to improve water-solubleDioscorea diosgenin, saponins from the Central Plains and the total contentof methyl protodioscin of more than60%. The establishment of water-solublesaponins measured by the standard and medicinal herbs and preparations byhigh performance liquid fingerprint reproducibility, precision, goodstability, good fingerprint similarity, improvement of Dioscorea injectionof the quality control method.