Study On Compound Sanqidan Capsule

[Objective] Sanqidan Capsule is a compound preparation of TCM treating type 2 diabetes and its complications,it has the effcacy of"Yi Qi Yang Yin,Huo Xue Qu Yu".This thesis carried out a systematic study on the processing technology, quality standard and stability and pharmacodynamics of Compound Sanqidan Capsule, which laid a good foundation for its developing into the new TCM of the six category,and provided new research idea and method for exploiting new TCM for Prevention and cure to diabetes.[Methods] Orthogonal test was employed for selecting the optimum ethanol extraction process of Notoginseng and Salviae Miltiorrhizaeby the indexes of the contents of notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,and total solid matters.Study factors were ethanol concentration,ethanol-adding amount,extraction times,extracting time. The L9(34) Orthogonal table was used to arrange experiment.Inner ebullition was used in water extraction technology.Taking the content of AstragalosideⅣand total solid matters as the indexes, the optimum water extraction process was studied by Orthogonal design.The influence factors were as follows:solvent amount, the time of extraction and times of extraction. The L9(34) Orthogonal table was employed to arrange experiment.we study the concentration method,drying method and condition of granule producing,the bulk density,angle of repose and the critical relative humidity of the grabule was investigated.In order to prove the rationality and stability of the technology,the technology was enlarged 10 times for 3 batches.Referring to Chinese Pharmacopoeia(2005 edition,volume1) and interrelated documentation,the qualitative identification of Radix Astragali, Panax notoginseng, Salviae Miltiorrhizae and Mulberry Syncarp in Compound Sanqidan Capsules was carried out by TLC, the content of AstragalosideⅣwas determined by HPLC, the HPLC condition was as follows:the Hpersil ODS column (200mm×4.0 mm, 5μm) was used and the column temperature was 30℃, the mobile phase was Acetonitrile-water(32:68) with the flow rate 1mL·min-1,the detector was ELSD with the drift tube temperature 45℃and the carrier gas flow rate 1.5L·min-1.Preliminary stability of three batches of samples was studied during the period of nine months,under the condition of normal temperature and constant temperature accelerate(40±2℃, RH75±5%).The qualitative and quantitative indexes was detected respectively according to quality standard method.We studied the effect of compound Sanqidan Capsule on the experimental diabetic animal models by taking the blood glucose,the vatality of SOD and the content of MDA as the indexes.[Results] The optimum ethanol extraction conditions for P anax notoginseng and Salviae Miltiorrhizae were as follows:adding six fold of 60% ethanol,extracting three times,once 1.5h. The optimum water extraction conditions for the Radix Astragali,Mulberry Syncarp,and the residue of Panax notoginseng and Salviae Miltiorrhizae were as follows: 1.5 fold of 70% ethanol using as release solvent,30 mins extracing time for every time, adding six fold of bioling water,extacting three times,once 10mins. The formation technology condition was that the relative density of extract was 1.32-1.38 (60℃,by vacuum concentrating),and the drying condition was vacuum drying(80℃,-0.06MPa～-0.08 Mpa),the dry extract was broke up ,being mixed with some dextrin ,it was granulated in the method of dry pressing.The result of enlarged process showed that the technology was stable and re-producible.The quality standard wsa established. The relevant spots of Panax notoginseng,Radix Astragali,Salviae Miltiorrhizae and Mulberry Syncarp on TLC plates were clear without the interference of the blank control.The content of AstragalosideⅣwas determined by HPLC,which was simple, accurate,reliable and reproducible, and can be used to control the quality of Compound Sanqidan Capsule.The preliminary stability result showed that the samples did not changed distinctly with good stability.The pharmacology study results were as follws:the Compound Sanqidan Capsule could reduce the level of blood glucose of experimental rats and mice,it had no effcct on the level of blood glucose of normal mice,it could lmprove the antioxitant ability of experimental diabetic rats,it could improve diabetes significantly.[Conclusion] Results of the study shows that the preparation technology is reasonable,simple and feasibility,the quality of the product is stable,controllable,and the efficacy is good,which meets the needs of a modern chinese medicine.The results of the study provide experimental evidence for the clinic trial and the industry scale production of Compound SanqidanCapsule.