Research On Preparation Of Injection With Herba Leonuri (Producing Needle) And The Quality Control

The lyophilized powderinjection of leonurusis a new type of traditional Chinese medicine(TCM)preparations which extracted by single leonurus.As the research object,this paper starts with medicine leonurus to its chemical composition,pH armacological action,clinical application,the existing preparation and quality control,etc are reviewed.This paper studies the extraction process of aqueous alcohol sink of leonurus,drawing the conclusion that the main influencing factors of the extraction process are the dosage of solvent and alcohol sink temperature.And at the same time,the preliminary extraction process of the stachydrine of leonurus is studied,the purified resin DM-3 is selected the best one,which is conducted the further research and the appropriate separation condition is confirmed.We obtain the preliminary purification of stachydrine of leonurus samples finally.Firstly,this paper studies the freeze-dried preparation methods of drug solution,founding evaluation index like the form ability,appearance,solubility and clarify degree of lyopHilized powder and selects the three accessories like mannitol,lactose and glucose,studying the variety,dosage and formability,exterior colour and luster of accessories influenced by precool time respectively.Then the prescription and preparation process of leonurus injection is confirmed and the stability of it is studied preliminarily.Secondly,leonurusstachydrine injection is conducted by the influencing factors of the experiment,accelerating experiment and room temperature sample experiment.Finally the author adopts the method of HPLC,establishing 10 batches offinger-print of leonurusstachydrine injection.The quality control standards of leonurusstachydrine injection are studied.The comparison of HPLC finger print of leonurusstachydrine injection shows that its preparation craft has good stability and reproducibility.