Preparation And Quality Study Of Hydroxypropyl Cyclodextrin Inclusion Powder Of Zedoary Turmeric Oil

The article designed Hydroxypropyl-β-cyclodextrin (HPCD) inclusion complex to improve the solubility and security, relieve the renal toxicity and hemolytic effect of the Zedoary turmeric oil. The aim of this article was to study the HPCD inclusion complex of Zedoary turmeric oil, and then established the methods of preparation and characterization of Zedoary turmeric oil lyophilized powders. Through using the method, the Zedoary turmeric oil lyophilized powders were prepared, then taking Zedoary turmeric oil injection as reference, studied the freeze-dried powders for safety evaluation. The results will provide theoretical bases for the development and utilization of traditional Chinese medicine injections, The main method and results are as follows:The optimal process conditions for the preparation of HPCD inclusion complex of zedoary turmeric oil using saturated water solution method was studied by orthogonal experiment design, considering the benefits and cost. The encapsulation efficiency were measured by he high performance liquid chromatography (HPLC), the results indicated the optimum preparation conditions for inclusion were established as follows:the ratio of zedoary turmeric oil and HPCD was1:15, inclusion time was1h,inclusion temperature was20℃. Agitation rate was500r/min.After the study of freeze-drying conditions, the optimal preparation procedure of lyophilizing zedoary turmeric oil powders was:Freezing the products for24h in-20℃refrigerator in advance; vacuum degree maintaining4～10Pa; freeze-drying for72h. The Zedoary turmeric oil lyophilized powders have good water solubility, good appearances and high inclusion efficiency.DSC, FT-IR, TLC, HPLC confirmed that the Zedoary turmeric oil entered into HPCD indeed. The stability test indicated that Zedoary turmeric oil lyophilized powders in the light, temperature and humidity conditions are good stability and good water solubility.The safety of Zedoary turmeric oil lyophilized powders were evaluated by acute toxicity test and hemolytic test. It indicated that, there was no hemolyzation in the common test tube method in vitro and the safety of the results meets the requirements.