Study On Preparation Of Shuanyimian Tablets And Its Pharmacodynamics Of Improving Menopausal Syndrome

Each woman has to go thro?gh the stage of female menopause.The pathogenesis of the menopausal syndrome is the ovarian failure.Female menopause patients suffer from a series of diseases,so their living quality and happiness decrease seriously.Nowadays,the side effects of clinical dr?gs usd in menopausal syndrome can't be ignored,and these dr?gs are also lack of compliance.The patients are willing to eat some health care products which regulate their body function and alleviate the symptoms.Based on this market demand,this study has developed tablets which can improve the sleep of female menopause patients and regulate their endocrine by supplementing herba epimedium into Suanzaoren decoction which is a great Chinese medicine.The study included the preparation process,quality standard and function of the tablets.The total flavonoids and total sapanins were investigated as the evaluation index.The soak time,solid-liquid ratio,extraction time,extraction times were investigated in turn.Each of them were selected about these levels,and then,these levels were used to design an orthogonal experimental.Through the intuitive and variance analysis,the best extraction process was optimized.The moisture absorption of the extract powder,the types and dosages of diluents,adhesives,disintegrating agent,lubricant were investigated to guarantee the best technology of tablets.Epimedium and Semen ziziphi Spinosae were identified by TLC.The icariin and jujuboside A were as the evaluation index of tablets.HPLC-UV and HPLC-ELSD were established successively to determine the contents of icariin and jujuboside A of the tablets.Both of methods had be verified.Finally,the rats model of female menopause and insomnia was established to observe the effects of tablets on the weight change value,indicators of sleep,the contents of E₂ and FSH of these rats.The results showed that the methods which we used to determine the contents of total flavonoids and total saponins were reliable and specific.The total flavonoids'recovery rates were in range of 96.19%-102.29%,The recovery rates of total saponins were in range of95.53%-102.47%.The optimal extraction process of Shuanyimian tablet was confirmed.The soak time was 15 minutes,solid-liquid ratio was 12,extraction time was 1.5 h,extraction for3 times.The concentration was 0.91/mL of the concentrated liquid.The relative density was1.08.Concentration was dried in a vacuum drying chamber with 70?.The percentage of the hygroscopicity of that extract powder was 17.20%,1g lactose-MCC?1:1?were as the diluents,95%ethanol was as the adhesives,5%PVP and 1.5CMS-Na was as the disintegrating agent,0.5%magnesium stearate was as lubricant.The weight of tablet was 0.6 g.The critical relative humidity of granules was 64.80%.The appearance of tablets was complete and sooth,the weight difference,hardness,disintegration time of tablets met the requirements.In the study of quality standards,the methods which were used to identify the Epimedium and Semen ziziphi Spinosae were reliable and specific,the methods which were used to determine the contents of icariin and jujuboside A were reliable and specific,the recovery rates of icariin and jujuboside A were in range of 95%-105%.In the study of function of tablets,it was successful to establish the rats model of female menopause and insomnia.To compared with the model group,Shuanyimian tablet had no direct sleep effect on these rats,but it not only could effectively prolong rats sleep time that was induced by pentobarbital sodium?p<0.01?,but also co?ld markedly increase the incidence rate of sleep induced by pentobarbital sodium whose dose was the maximum subthreshold dose.Compared with the model group,Shuanyimian tablet could reduce the weight gain of the model rats,could markedly raise the level of the estradiol?p<0.05?and reduce the level of the follicle-stimulating hormone.In summary,these methods,which be used in this study to determine the contents of total flavonoids and total saponins,were reliable and specific.The best preparation process was stable and had a strong operability.All of those qualities met the requirements.The methods which were used in this study to determine the contents of icariin and jujuboside A were reliable and specific;this tablets could improve the sleep and regulate the endocrine system.