| The medicament assists material is very important in medicine preparation. With the development of macromolecular material, the improvement of people's demand, and the unceasingly improvement of forms and preparation handicraft of drug, the world medicament assists material industry, which people also pay good attention to ,has developed very prompt. The traditional subsidiary material cannot be satisfied with modern traditional Chinese medicine preparation, but it brings about a new problem when we try to use a new kind of medicament assists material: the application of new assists material may have bad effect on the character and curative effect of traditional Chinese medicine preparation. For finding out this problem, we choose a kind of typical subsidiary material widely used for study, which contains the quality and stability of the main medicine and the subsidiary material before preparation and after preparation.This paper systematic research assists material polyacrylic resinâ…¡'s various indexes before preparation and after preparation, taking Yiqing tablet, Sanhuang tablet and Fufang Danshen tablet as carriers. First we made a study of polyacrylic resinâ…¡'s quality, investigating outward appearance and properties, acid value, loss on drying, arsenic salt and so on. We use infrared spectroscopy for identification, use HPLC determination for limit of monomers, titrate with 0.1N sodium hydroxide for contents of methacrylic acid (C4H6O2) units. Then our survey points at quality of polyacrylic resin II after preparation, mainly about identification, inspection of limit of monomers and contents determination in this assists material of the three tablets. After this work, a new quality research method has been initially established, which used the simulated sample prepared as the same process for contrasting. We values three arrays of samples by the method and it is proved that polyacrylic resinâ…¡was excellent in stability before preparation and after preparation.Meanwhile we have studied the main medicine in preparation, in order to discuss whether the assists material polyacrylic resinâ…¡had the bad affection to main medicine's quality. It is showed that using assists material not only had any effect about the overall outward appearance but also improved the stability of the preparations, after we investigated the outward appearance, identification and contents determination of the main medicine. We compare the main medicine before and after preparation in the three kinds of tablets by TLC identification. From the experimentation we are told to that all the three arrays of samples which have been coated with polyacrylic resinâ…¡can detect each characteristic composition. HPLC determination result has revealed that contents of the characteristic compositions baicalin in Yiqing tablet, total emodin and chrysophonol in Sanhuang tablet and tanshinoneâ…¡A in Fufang Danshen tablet are up to the mustard. Taking one with another, the quality of main medicine before and after preparation is very consistent.We also conducts the accelerated stability test in this paper about the three arrays of the three Chinese medicine samples, samples without coating and assists material polyacrylic resinâ…¡in the samples. It is resulted that the samples without coating are basically satisfied in identification, detection, time limit of breaking and contents determination, but moisture contents increased. In these three months' accelerated stability test, the polyacrylic resinâ…¡and main medicine, in the three arrays of the three Chinese medicine samples, all have little change in every aspect. It is prompted that the assists material polyacrylic resinâ…¡and the main medicine are all good in stability, using the assists material polyacrylic resinâ…¡can increase the stability instead of doing bad for the quality of main medicine.Our works try to add the quality research of assists material to the quality study of Chinese medicine, in order to offer a scientific basis for improving the quality evaluation standard of Chinese medicine and laying the foundation for the application and promotion of medicament assists material. |