Preparation Technology And Quality Standards And Preliminary Stability Of New Yixinningshen Tablet

ObjectiveBased on the preparation method of New Yixinningshen tablet,this article utilized the single factor orthogonal experimental method to screen the auxiliary material and complete the preparation process of New Yixinningshen tablet;and the quality standard of New Yixinningshen tablet was studied;meanwhile,the stability of New Yixinningshen tablet was preliminarily studied.The purpose of this study is to develop a new dosage form of sedative and hypnotic therapy for the treatment of neurasthenia.MethodsSingle factor experiment and orthogonal experiment were used to screen the supplementary materials of New Yixinningshen tablet,and to determine the preparation process of New Yixinningshen tablet.Schisandra chinensis and Acacia flowers of New Yixinningshen tablet were identified by the thin layer chromatography(TLC),and high-performance liquid phase chromatography(HPLC)method for the determination of New Yixinningshen tablet in rutin,quercetin,quercitrin,schisandrin A,schisandrol B.At the same time,the content of the schisandrin A was compared with the simple comparison of Yixinningshen tablet.By accelerating the stability of the investigation method,New Yixinningshen tablet was investigated.ResultsAfter a series of experiments,we finally determined the best preparation technology of New Yixinningshen tablet' s new prescription for 10g ofginseng stem leaf total saponin,Albizia julibrissin 500g,Schisandra 500g,500g of Ganoderma lucidum and 85% ethanol amount,calcium sulfate 18g,pregelatinized starch 12g,starch 28g,30g of microcrystalline cellulose,1%magnesium stearate,0.5% talcum powder.TLC spots were clear and the negative control had no interference.Rutin,quercitrin,quercetin,schisandrin A,schisandrol B respectively in the sample volume for 0.13 ~ 8.30 ?g(r=0.9996),0.13 ~ 8.32 ?g(r=0.9995),0.12 ~ 7.84 ?g(r=0.9997),0.12 ~ 7.49 ?g(r=0.9998),0.13 ~ 8.07 ?g(r=0.9998)range peak area and concentration wasgood linear relationship.The average content was 1.1839,7.3307,0.2507,4.9066,1.2935 mg per piece,RSD values were 1.25%,0.41%,1.60%,0.62%,0.68%.New Yixinningshen tablet in the accelerated stability conditions for 6 months,and its quality is stable.ConclusionsIn this study,we determined the best preparation process and established the quality standards of New Yixinningshen tablet.The experimental results showed that the tablet weight difference of New Yixinningshen tablet was in line with the provisions;the TLC method was simple and reliable for the qualitative identification of New Yixinningshen tablet;A high performance liquid chromatography method was used to measure the composition with simple operation,good repeatability and no interference of excipents,which can be used for the quality control of New Yixinningshen tablet.Kept in the accelerated stability conditions for 6 months,the quality of New Yixinningshen tablet was stable.