Study On Preparation Technology,Quality Evaluation And Stability Of Orostachys Fimbriatus(Turcz)Berger Total Triterpene Capsules

As the whole plant of ascetiaceae,Orostachys fimbriatus(Turcz)Berger is rich in triterpene,saccharide,sterol,flavonoids and other chemical components.Modern pharmacological studies have shown that Orostachys fimbriatus(Turcz)Berger has antibacterial,anticancer,cardiac-strength,anti-hemolysis,antiviral and immunomodulatory effects.This paper aims to make a comprehensive study on the extraction and purification of total triterpenes from Orostachys fimbriatus(Turcz)Berger and the preparation process,quality evaluation and stability of total triterpenes capsules from Orostachys fimbriatus(Turcz)Berger.First,the extraction process of triterpene from Orostachys fimbriatus(Turcz)Berger was studied.Triterpenes in Orostachys fimbriatus(Turcz)Berger were extracted by three extraction techniques including thermal reflux extraction,ultrasonic and microwave extraction.The results of thermal reflux extraction showed that the optimal extraction process of total triterpenes was as follows: ethanol concentration of 85%,solid-liquid ratio of 1:8(g/mL),heating reflux extraction twice,120 min each,the number of mesh was 50.Under these conditions,the extraction rate of triterpenes was 8.12mg/g.Ultrasound extraction results show that the optimum extraction technology of total triterpenes as:the number of mesh was 100,the extraction temperature was59℃,the ethanol concentration was 75%,the dosage of solvent was 17mL/g,the ultrasonic power was 201 W,and the ultrasonic time was 50 min.under this condition,the extraction rate of triterpenes was 5.79mg/g.The microwave extraction results showed that the best extraction process of total triterpenes was:ethanol concentration was 82%,microwave power was 500 w,the extraction time was 5min,the extraction temperature was 50℃,the number of mesh was 60,The ratio of feed to liquid is 1:15(g/mL).Under these conditions,the extraction rate of triterpenes was8.39mg/g.The above results provided the experimental basis for the extraction of triterpenoids from Orostachys fimbriatus(Turcz)Berger,the microwave extraction and thermal reflux extraction have higher extraction rate,and the difference between them was not significant.Considering that thermal reflux extraction is easier for industrial production.Therefore,the thermal reflux extraction technology was used to prepare thesubsequent test materials.Secondly,the purification of triterpenes from Orostachys fimbriatus(Turcz)Berger by macroporous adsorption resin was studied.According to the adsorption rate and desorption rate,the resin LSA-21 type with the best purification effect was selected by static adsorption method.By investigating the influence of various factors on the resin adsorption and desorption effect,the optimal dynamic adsorption conditions were optimized as follows:the concentration of the upper column liquid was 3.12mg/mL,the loading amount was 203 mL,the adsorption rate was3BV/h,the pH of the upper column liquid was 6,the concentration of the alcohol of the desorption agent was 70%,and the dosage of the desorption agent was 180 mL,the analytic rate was 2BV/h.Under the condition of this process,the average adsorption and desorption rates were91.83% and 91.41% respectively,and the purity of triterpenoids in Orostachys fimbriatus(Turcz)Berger dry extract increased from 9.36% to 40.56%,increasing by 31.2%.Therefore,it was concluded that this process could effectively purify total triterpenes in Orostachys fimbriatus(Turcz)Berger.Furthermore,in vitro antioxidant activity of triterpenes was studied.The scavenging ability of DPPH free radical,ABTS free radical and superoxide anion free radical was studied.In general,the triterpenes of Orostachys fimbriatus(Turcz)Berger have strong antioxidant properties.The scavenging ability of DPPH free radical was higher than that of vitamin C.ABTS free radical scavenging ability is slightly lower than vitamin C.The scavenging ability of superoxide anion radical was lower than that of vitamin C.Finally,combined with the optimal extraction and purification process of total triterpenoids from Orostachys fimbriatus(Turcz)Berger,the preparation process of total triterpenes capsules was studied.With hygroscopic rate and resting Angle as the evaluation indexes,the optimal preparation conditions of the capsules were determined.The optimal excipient was microcrystalline cellulose,the ratio of excipient was 1:1,the critical relative humidity was 57.7%,and the capsule load was 0.4093 g.And factors influencing on the stability of capsule on the quality evaluation and experimental study,the results show that each contain total triterpenoidshall be not less than 128 mg,filling quantity differences are within ±7.5%,content of< 9%,disintegration time limit<30 min,ash content was <5%,TLC identification,heavy metals,arsenic salt have tested conforms to the standard,the stability influence factors experiment,capsule content color,status,total triterpenoid content has no obvious difference,the capsule prepared under these condition were in accordance with the relevant requirement of "Chinese pharmacopoeia 2015".