Zj Quality Standards Study

Precious chrysanthemum hypertension tablet consist by chrysanthemum indicum L. lotion powder, pearl layers of powder, hydrochloric acid clonidine, hydrochlorothiazide and rutin, Chinese and Western medicine preparation made of two or more ingredients that make up to step down the hypertension. Side have Western medicine pharmacology function of depressing hypertension, the more important thing is that it can also calms the nerves calmly , adjust and reduce the fat of blood, dispel the artery sclerosis; Improve endothelial cell, brain cell, kidney cell's function; Improve blood circulation peculiar suiting high blood pressure complicated functioning of mechanism traditional Chinese medicine. The ones that incorporated Chinese medicine theory and modern medical theory, laboratory research and clinical experience into an organic whole were made well up .It is base on the premise that clinical curative effect is reliable that this subject is studied, carry on systematic research to the hypertension tablet of precious chrysanthemum in terms of pharmacy, establish the foundation for developing this preparation into a new medicine. Subject this adopt experiment analytical method at first , set up precious chrysanthemum hypertension tablet determine the nature differentiation method , preparation measure project and high-efficient liquid phase chromatogram legal analytical method of quantity. Determine respect carry on method study research , is it control this preparation quality of quality accuse of the index to make in content. Adopt high-efficient liquid phase chromatogram law determine hydrochlorothiazide , hydrochloric acid content that clonidine, have made its limit of content. Adopt high-efficient liquid phase chromatogram law through determine chrysanthemum indicum L. lotion powder main effective composition cover with content to spend linarin, to control the quality of the lotion powder of chrysanthemum indicum L. in preparations , make its limit of content at the same time . Study preliminary stability investigation to 3 batches of samples through accelerating the experimental law (37 ℃, 75%).The result of study of the quality level shows : Finished product include hydrogen chlorine thiophene piperazine , that coke make each of quantity can't less than label 115.0% of quantity hydrochloric acid; Include the mother chrysanthemum and regard covering with linarin (C₂₈H₃₂O₁₄ ) and counting the average content as 0.23mg. The method learns to show in result of study: The stability , precision , rate of recovery of this method accord with the quantitative analysis requirement , the quality that can be regarded as a product accuses of the index .The preliminary stability result shows : Form of this product, distinguishing , checking, the content is determined,etc. None has changed within 3 months, prove the quality within 2 years of a product is steady.