Studies On Preparation And Quality Standard Of Baogan Pill

Baogan pill is a purified extract from traditional Chinese medicine, composed of amixture of thirteen main components: ginseng, scrophulariaceae, licorice and so on. Thisextract has been verified to be able to be used as a medicine for promoting liverregeneration, terminating cirrhosis and liver ascites, reversing fibrosis and elevatingalbumin efficacy. To make it used as hepatoprotectant, this review addresses a number ofrecent studies showing preparation technology and content determination in detail.For this purpose, this review will cover the following aspects:1. The extraction process and preparation process.The extraction process: depending on the nature of each medicine, we conducted asystematic study about the extraction technology with orthogonal experiments. Inconclusion, the ginseng is extracted with water; the licorice acid is extracted with70%methanol under reflux; herbs A, G and H are extracted with water together; herbs D,peony and scrophulariaceae are extracted with80%methanol together; herbs I, B, C, Eand F are madein powder medicine without extracting. Moreover this method is simple,stable and high extraction rate.The preparation process: we examine the preparation of Baogan pill and get the bestconclusion (1000g,300ml70%methanol,50℃).2. Identification of Baogan pill.Microscopic identification: we observe the characteristics of the internalorganization structure, cell shape and containing herbs for Herbs B, C and E using theway of microscopic identification. The results show that Herb E can be used as theidentification basis with its organizational characteristics cells.TLC: we conducted TLC studies with Red peony, Chuanxiong, Atractylodes andHuang Jing using the reference of paeoniflorin. The results show paeoniflorin can be thereference because of its negative non-interference, high specificity and reproducibility.3. Determination of the content.The content of the harpagoside, licorice acid, ginsenosides Rg1, Re and Rb1aredetermined by HPLC and we make the methodological study. The harpagoside is extracted with30%methanol in the field of ultrasound for40minutes and analyzed by RP C18HPLC [MeCN/1%(HAc/H2O)=28:72,1.0ml/min,monitored at278nm]. The methodological study show the linear relationship of theharpagoside can be identified by HPLC in the range of0.04-0.40μg. Moreoverdetermined the minimum of70μg/g.The licorice acid is extracted with70%methanol in the field of ultrasound for40minutes and analyzed by RP C18HPLC [MeCN/0.5%(H3PO4/H2O)=37:63,1.0ml/min, monitored at250nm]. The methodological study show the linear relationship ofthe licorice acid can be identified by HPLC in the range of0.78-2.36μg. Moreoverdetermined the minimum of219μg/g.The ginsenosides Rg1, Re and Rb1are extracted with methanol under reflux andleached with N-butyl alcohol and analyzed by RP C18HPLC [MeCN/0.5%(H3PO4/H2O), gradient elution,1.0ml/min, monitored at203nm]. The methodological studyshow the linear relationship of ginsenoside Rg1, Re and Rb1can be identified by HPLCin the range of1.60-3.20μg,1.70-3.60μg and2.10-4.30μg. Moreover determined theminimum of270μg/g which is the addition, the precision, stability and repeatability arevery pleased.4. The study related to the quality standards of Baogan bill.After examining water content, content uniformity, weight variation and dissolvetime limit, the products meet the requirements about water pills in the "ChinesePharmacopoeia"2010edition one Appendix ⅠA. Check the project results show that thisproduct is conform to the requirements of the pharmacopoeia, belongs to the qualifiedproducts.