Study On The Preparation Technology And Quality Standard Of Baijin Capsules

ObjectiveThe Baijin capsule,which is composed with some kinds of traditional Chinese Me dicine such as radix curcumae,albizia julibrissin,etc.It can relieve depression and soothe the nerves and is mainly used in the cure of Depression.Due to the cause and patho genesis of depression is complex and diverse clinical presentations,it is a hot research to develop a better efficacy,rapidly onset,less adverse reactions of antidepressant drug.In this thesis,modern technical methods were used to optimize the extraction and puri fication process,determine the preparation technology of capsule and establish the preli minary quality standards of capsule.Methods1 Study on raw material extraction and purification process:The extraction and p urification process of Curcuma longa was determined with the content of Curcumin as an indicator.The extraction procedure of Albizzia julibrissin Durazz was determined by orthogonal test with the contents of total flavone and quercitrin as indexs.With the content of total flavonoids as index,purification technology was optimized by investig ating the concentration of sample liquid,type and amount of eluent,impurity solvent,et al.The extraction procedure of Radix paeoniae Alba was determined by orthogonal test with the contents of total glucosides of Paeony and paeoniflorin as indexs.The extract ion and purification process of Valeriana jatamansi was determined with the content of 11-ethoxyviburtinal as an indicator.2 Study on moulding process:To select different indicators on the choice of acce ssories and the dosage was applied to optimize the molding proces of Baijin capsule.3 Quality standard research:By using TLC,we made qualitative analysis on each constitute of Baijin capsule;By using HPLC,we made quantitative analysis on Paeoniflo rin.Results1 Curcuma longa:6-fold,75%ethanol extract 2 times,1.5 hour everytime,the mac roporous resin model was S-8,the concentration of extract was 0.5 g·mL-1,the ratio of polyamide to crude drug was 5:3,the flow speed for adsorption was 2BV/h,the flow sp eed of elution agent was 3 BV/h,80%alcohol was chosen as elution agent,the dosage of elution agent was 5 BV.Albizzia julibrissin Durazz:12-fold,70%ethanol extract 2 times,2hour every time,the macroporous resin model was AB-8,the concentration of extract was 0.2 g-mL-1,the ratio of polyamide to crude drug was 5:2,the ratio of diam eter to height of polyamide column was 1:8,the flow speed for adsorption was 3 BV/h,the flow speed of elution agent was 3 B BV/h,50%alcohol was chosen as elution a gent,the dosage of elution agent was 5 BV.Radix paeoniae Alba:14-fold,70%ethanol e xtract 3 times,1.5 hour everytime,the macroporous resin model was AB-8,the concentra tion of extract was 0.2 g·mL-1,the ratio of polyamide to crude drug was 4:3,the ratio of diameter to height of polyamide column was 1:8,the flow speed for adsorption was 3 BV/h,the flow speed of elution agent was 3 BV/h,50%alcohol was chosen as eluti on agent,the dosage of elution agent was 5 BV.Valeriana jatamansi:12-fold,70%ethanol extract 2 times,2 hour everytime,the macroporous resin model was AB-8,the concentra tion of extract was 0.2 g·mL-1,the ratio of polyamide to crude drug was 25:13,the rati o of diameter to height of polyamide column was 1:6,the flow speed for adsorption w as 2 BV/h,the flow speed of elution agent was 4 BV/h,70%alcohol was chosen as el ution agent,the dosage of elution agent was 5 BV.2 Baijin Capsule’s preparation technology is determined.The prescription extract i s mixed with 1 times the excipients,of which microcrystalline cellulose:lactose=7:3,coll oidal silicon dioxide is equivalent to 3%of the total mixture.Adjusting rolling wheel pressure to 4 MPa and speed to 16 Hz,the total mixture is crushed and granulated by dry granulation.Then capsule is made.3 Baijin Capsule’s quality standard is initial established.The components were ev aluated by TLC,including Curcuma longa,Albizzia julibrissin Durazz,Radix paeoniae Al ba,Valeriana jatamansi.The content of Paeoniflorin was determined by HPLC method.ConclusionA stable and feasible preparation process of Baijin Capsule is established by the r esearch of extraction,purification and moulding process.The quality standard is sensitive,accurate and specific.In conclusion,the corollary of the experiment has reached the anti cipant goal.