Studies On Preparation Technology And Quality Standard For Zhenyin Buccal Tables

The survey of oral epidemiology conducted in 2006 showed that dental prevalence has gone up to 97.6%,and the incidence of dental diseases listed in the following tumor and cardiovascular and cerebrovascular disease;dental caries and periodontal disease are the most common and the high incidence of dental disease.With serious damage to the teeth in the mid-and late caries,a way to fill must be used to terminate the development of the disease of the formation of cavities.Early prevention and treatment of dental caries can retain a healthy natural teeth and reduce the incidence of illness,so it will get more and more widespread attention.At present,western medicine are the main drugs for the treatment of early dental caries on the market,however,there is normally a big side-effects.Chinese medicine has fewer varieties to treat the early dental caries.And currently listing buccal tablets with good taste have not been seen on the market.Our subject has aimed at a dental caries-specific medication in the field of traditional Chinese medicine,and the dosage form chooses buccal tablets which can produce longer effect in the mouth.The prescription involved in our study has been quoted from a professianal recipe which is based on anti-bacterial experiment and has a clear effect. The article aims to develop some kind of new medicine through the research of its preparation technology and quality standards.During the course of the research on extraction&purification process,based on our analysis of each individual component contained in each herbal medicine in its pharmacological action, pharmadynamics,physica]&chemical property,as well as the main action of the whole recipe,its extraction process has been classifed into two parts,i.e.Fructus Ligustri Lucidi was extracted by ethanol;and Radix Glycyrrhizae and Flos Lonicerae by water.According to L₉(3⁴) orthogonal survey conducted with the content of Oleanolic acid as appraising index,we concluded that the optimum process for extraction by ethanol would be:by heating circumfluence,use 9 times 70%ethanol to extract twice,1 hour for each time.In the same way,we decided the best process for extraction by purified water,i.e.used 8 times water,and boiled three times,1.5 hours for each time;and the alcohol-sinking process:the alcohol-sinking solution to be made into 70% concentration with the proportion of(raw materials and liquid) 1:1 after 12 hours of alcohol precipitation.The validation tests verify the reasonable and feasible of the extraction and purification process.In our study on its tablets-forming,we decided a final forming process based on different kinds of contents,and proportion of forming auxiary materials and dosage of Aspartame.We concluded that when ratio of liquid extract against mannitol is kept at 1: 4 and with Aspartame content of 1%,it is in a better condition to be formed into a well-mixed gradules which can be pressed tablet with good taste and good color.Three amplification test verify the reasonable and feasible of the preparation process.In its quality control study,the research conducted for the quality standards of the buccal tablets has included the TLC and content analysis of Oleanolic acid.We have a qualitative identification on Zhenyin buccal tablets,it comes out obviously. In accordance with Chinese Parmacopoeia(2005 Rev.),a methodological survey has been conducted on the content analysis of Oleanolic acid,and it concluded:good linear indications has been shown as a result of the injection for HPLC being controlled within 0.1988-3.3133μg,r=0.9999;the sample solution remains in a stable condiction within 24hrs,RSD%at 0.49%;samples recovery rate at 99.48%,RSD%at 1.63%;Concentration designed for a survey ranges from Minimum of -20%to Max.of 50%,its accuracy(from Min to Max.):0.87%,1.18%,1.01%.Our experiments has demonstrated that above-mentioned method is easy for manipulation and correct identification,and the bland solution had no interference, therefore can be adopted for its quality control.