Squeeze Contraction - Expansion Round Of New Technologies Preparation Of Pills

Pellet is a new dosage form among Traditional medical pills, having the characteristics of pill, powder and granule and commonly used in clinical medication. It includes fast- and sustained-release pellets and vacant pill cores in terms of clinical needs. As a new modern dosage form, pellets possess great development potentials.Currently, there are many preparative methods of pellets, but some defects still exist. For example, high consumption of excipients, complicated process, low product yield and high requirements to equipments. Besides, the pellets prepared by the technique available still have the following common problems to be solved such as high cost of preparation, low antihydroscopicity, poor degree of circularity and so on.Our study commences on the forming technology and brings in a new preparative technique of pellets named "Extrude-condense-expand-be circle" technique to solve the common problems existing in the pellets of traditional Chinese medicines. The studies were involved on the adaptability of the new technique to different materials, the basic characteristics of pellets and some improvement of the new technique, etc.As to the part of adaptability of the new technique to different materials, the technique of "Extrude-condense-expand-be circle" technique was performed to the pellets of traditional Chinese medicines with the commonly used raw materials (full extract, the mixture of extract and crude drug powder, full crude drug powder and crude drug); the adaptability of the new technique to varied materials were determined by the investigation of technology parameters and by the comparison of the basic characteristics of the pellets.Duyiwei Pellets were set as model drug to study the basic characteristics of the pellets. The comparison between the pellets prepared by 2 techniques were made in the following aspects: appearance, dissolution time, surface degree of circularity, bulk density, hydroscopicity, critical relative humidity (CRH), dissolution rate, and quality specification. The results indicate that the "Extrude-condense-expand-be circle" technique can reduce the consumption of excipients,the cost of the preparing time. At the same time, the basic characteristics of the pellets which prepared by the newly emerging technique were all qualified. So, the "Extrude-condense-expand-be circle" technique is superior to the traditional pill-preparing technique and the test drug quality was not affected.As the traditional exsiccation technique of drying oven had been used to prepare pills before, the microwave vacuum dehydration was applied as improvement. The production efficiency was increased greatly and better degree of circularity of pellets was obtained.The study results suggest that the"Extrude-condense-expand-be circle" technique is better than the commonly used ones in solving the common problems in the traditional medical pellets, thus showing a broad prospects for farther development and application and providing new thoughts for the study on new pharmaceutical technology.