Pharmaceutical Study On Yangjingzhongyu Decoction Preparation

Objective:The prescription of Yangjing Zhongyu decoction agent is from “Fu Qingzhu gynecology” articles of Zhongzi. It consists of Radix Rehmanniae Preparata, Angelica Sinensis, Radix Paeoniae Alba, Dogwood, four herbs composition. It has potent activity of kidney reinforcing and blood nourishing for treatment of infertility. This research was based on clinical soup dosage and processed study, by prescription analysis and dosage from selecting and prepared Yangjing Zhongyu decoction agent.The research dealed with preparation process study, quality standard study, fingerprint and preliminary stability in order to research a safety, convenience, and effective new medicine.Methods:(1)Study of preparation technology: Through L9(34) orthogonal test, the adding amount of water, extraction time, extraction times were investigated, to Loganin, Paeoniflorin in the extract solution and the yield of the dried extracts as the index, to determine the best extraction conditions; Through the enrichment experiments, pressure, temperature and relative density of concentration are investigated to determine the appropriate process research on materials for study, optimize the proportion of suitable materials and determine the finished terminal sterilization methods of decoction agent. The whole preparation process smooth, reasonable and stable.(2)Study of quality standard: Angelica Sinensis, Radix Paeoniae Alba and Dogwood in this medicine were identified by TLC. The content of Loganin, Paeoniflorin were determined by HPLC. To establish the quality standard of Yangjingzhongyu Decoction Preparation.(3)Study of fingerprint Analysis:Using the method of HPLC, to the loganin as the reference peak, to establish the fingerprint of the study of yangjingzhongyu decoction.(4) Study of preliminary stability: We examine long term stability and accelerated stability of Yangjingzhongyu Decoction in the aspects of properties, relative density,insoluble, TLC, the determination of the content etc for 6 months, respectively.Results:(1) The extraction conditions were as follows: 6-fold water, extracted 60 min for 3 times. The condition of concentration: 60~90℃ at 0.95 MPa, Liquid relative density is 1.21~1.28.(2) The optimum condition of the method TLC and the HPLC method of Loganin, and Paeoniflorin, and the creation of a draft standard of Decoction.(3)There were mainly 14 characteristic peaks in the fingerprints. Among these peaks, 6 peaks belonged to Dogwood, 4 peaks belonged to Radix Paeoniae Alba, 1 peaks belonged to Angelica Sinensis(4) That the above parameters were not changed significantly indicates a good stability of the preparation.Conclusions:The preparation procedure is reasonable, stable and feasible, and can be used for industrial production. The methord of quality standard and fingerprint is reliable, accurate and repeatable, can be used to control the quality of yangjingzhongyu decoction.