| Nocturnal enuresis is an ordingary disease in children,TCM has its own characteristic and superiority in treating it.The research of Nocturnal enuresis is very active. Some new drugs are put to the market,but the investigation drug's clinical property shows that these drug's curative effects are not good. The purpose of this project is to develop a safety,effective medicament that can prevent and curethis disase.In the course of study, this recipe has been developed into a more convenient from of Chinese medicine Granules based upon our study on its preparation process, quality standard.During the course of the research on extraction process, based on our analysis of each individual component contained in each herbal medicine in its pharmacological action, pharmadynamics, physical &chemical property, as well as the main action of the whole recipe and the facture is entirety by water. Alpinia oxyphylla Miq.and Cinnamomum cassia Presl ware water steam distillation with volatile oil draw for using medicine effective component availly by water .vola- ile oil add to granules through B-cyclodextfin inclusion compound; mdeicine liquid add to water from Ephedra,Gallus gallus domesticus brisson,Cuscuta chinensis Lam and Ginkgo bilob to condense thick grease. According to L9(34) orthogonal survey conducted with dry extraction quantity & content of ephedrine hydroehloride as appraising Index, we concluded that the optimum process for extraction by purified water, i.e. used 10 times water respectively, and boiled two times, one and half hours for each time; volatile oil was extracted to add five times amount of water into the mixture of crude drugs, to soak the herbs for one hour, and to extract volatile oil for four hours.During the course of the research on purification process, According to L9(34) orthogonal survey conducted with dry extraction quantity & content of ephedrine hydroehloride as appraising Index, the optimum extraction process was : extraed with medicine liquid concentration to 1.06-1.08,40% the ethanol, sedimentation time was 12 hours.During the course of the research on inclusion process, According to L9(34) orthogonal survey conducted , the optimum inclusion condition was Volatile oil:β—CYD in proportion as 8: 1 was mixed,β—CYD : water in proportion as 1: 4 was mixed, the inclusion time was 30 minutes.In our study on its granules-forming, we decided a final forming process based on our research on concentration of the liquid extract, different kinds of contents, and proportion of forming auxiary materials: ointment: assistant material in proportion as 1: 4.5 was mixed and powdered sugar: dextrin in proportion as 3.5:1 was mixed , the corrective dosage of Aspartame,citrat,orange sapor was 0.5%,1%,0.5%,it is in a better condition to be formed into a well-mixed gradules with good taste and easy dissolution.In its quality control study, the research conducted for the quality standards of the gradules has included the TLC and content analysis of ephedrine hydroehloride . We have a qualitative identification on XiaoErYiLiaoNing gradules with Alpinia oxyphylla Miq.herb, ephedrine hydroehloride contrast,Gimkgo biloba C as comparative samples. In accordance with Chinese Parmacopoeia ( 2005 Rev.), a methodological survey has been conducted on the content analysis of ephedrine hydroehloride, and it concluded: good linear indications has been shown as a result of the injection for HPLC being controlled within 51-1020ng, R=0.9999; the sample solution remains in a stable condiction within 24hrs, RSD% at 1.27 %; its accuracy RSD% at0.82 %;samples recovery rate at 98.36%, RSD% at 1.45%; Concentration designed for a survey ranges from Minimum of -50% to Max. of 200%, its accuracy( from Min to Max.): 1.03%, 0.82%, 1.10%. its veracity (from Min to Max.): 1.63%, 1.45%, 1.58% Our experiments has demonstrated that above-mentioned method is easy for manipulation and correct identification, therefore can be adopted for its quality control. |
