Studies On The Precedure And Quality Standard Of Xiaoyao Effervescent Tablets

Xiaoyao effervescent tablets are mailly constituted of Radix Bupleuri, Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Astractylodis Macrocephalae, Radix Glycyrrhizae, Poria, Herba Mentha, which was developed from Xiaoyao Pills—a traditional Chinese pateht medicine,first recorded in Taiping Huimin Heji Ju Fang. In order to enhance the biological utility of the drug, effervescent tablet is chosen as proper dosage form.In the procedure experiment, the volatile oil extraction method was studied. The best extraction conditions were: isolate the volatile oil from Radix Bupleuri, Radix Angelicae Sinensis, Rhizoma Astractylodis Macrocephalae and Herba Mentha by distillation for two hours. Orthogonal design was adopted to determine inclusion conditions of volatile oil. The optimum inclusion conditions were: combinethe volatile oil andβ-cyclodextfin at the rate of 1:5, and grind for 1hour. The decoction conditions of Radix Paeoniae Alba, Poria, Radix Glycyrrhizaee were examined by orthogonal test. The most decoction conditions were: decocte the herbs above with water for three times,1hour for each. The cdcoctions were filtered and concentrated to a thick extact with a relative density of 1.25-1.3, then dry in Vacuum, pulverize to fine powder, mix with amylon, effervescent disintegrants,volatile oil incusion, magnesium stearate and sodium cyclamate, make granules, dry, make into tablets.To control the quality of Xiaoyao effervescent tablets, the quality standard was set up. Radix Bupleuri, Radix Paeoniae Alba, Glycyrrhizae, Poria and Radix Angelicae Sinensis in Xiaoyao effervescent tablets were identified by the thin layer chromatography ( TLC), the method are simple and accurate. The content of the paeoniflorin was determined by High Performance Liquid Chromatography (HPLC). The linear range of paeoniflorin was 0.82-1.025μg,r =0.999 6. The average recovery rate was 100.44% ( RSD =2.37%).The preliminary and accelerating survey of the stability test were carried out. The identification, content determination of paeoniflorin and other requriments were observed.The results shows that, the precedure of Xiaoyao effervescent tablets is convenient and feasible,the quality control method is simple and accurate and the Xiaoyao effervescent tablets are stable.