Studies On Quality Standards Of Marsdeniae Tenacissimae Caulis, Polygoni Cuspidati Rhizoma Et Radix And Xiaoliu Capsule

Xiaoliu Powder is a folk recipe consisting of twenty ingredients. It has been used to treat hysteromyoma and ovarian dropsy in Yunnan Province of China. Deng and Shen have optimized the preparation process and the prescription of Xiaoliu Capsule, and established the quality control methods. Currently Marsdeniae Tenacissima Caulis lacks quantitative determination method with high-specificity, decoction pieces of Polygoni Cuspidati Rhizomaet Radix lacks quality control standards which are main crude drugs of Xiaoliu Capsule. In this thesis, we have researched quality standards of Marsdeniae Tenacissima Caulis and decoction pieces of Polygoni Cuspidati Rhizomaet Radix, to ensure the Xiaoliu Capsules we will produce are safe and effective. We also establisd an quantitative determination method of Salvianolic acid B to replenish the quality standard of Xiaoliu Capsule.Marsdeniae Tenacissima Caulis is the dried stem of Marsdneia tenacissima (Roxb.)Wight et Arn. This herbal medicine has been used as a remedy for cancer, pneumonia, trachitis, asthma, rheumatism, fracture and so on. Chinese Pharmacopoiea (VolumeⅠ,version 2010) has received it, yet lack quantitative determination method with high-specificity. These studies chose the special content-tenacissoside H as the signal substance and established an HPLC determination method with ELSD detector. We collected 11 samples from different habitats and measured their contents. The calibration curve was good linear in the range from 0.5625 to 36.00μg (r=0.9998). The average recovery and RSD were 99.40% and 1.75%, respectively. The contents of tenacissoside H calculated with reference to the dried drug in the 11 samples varied from 0.1483% to 0.6871%. It is proposed to contain not less than 0.12% of tenacissoside H calculated with reference to the dried drug.The method established in this paper is specific and reliable to control and evaluate the quality of Marsdenia tenacissima Caulis. It completes the quality standard of Marsdeniae Tenacissima Caulis.Polygoni Cuspidati Rhizomaet Radix is the dried stem and root of Polygonum cuspidatum Sieb. et Zucc. In Chinese Pharmacopoiea(2010 version), there is only processing method of its decoction pieces, so we had to research their shape and properties, TLC identification, moisture, total ash acid-insoluble ash, extraction and HPLC determination, in order to complete quality standard of decoction pieces. We collected 16 samples from different habitats and researched above items according to the methods in Chinese Pharmacopoeia 2010. According to the experimental results, the contents of moisture, total ash and acid-insoluble ash were 8.90%～10.93%, 2.07%～4.23% and 0.14%～0.89%, respectively. The content of extraction was 11.38%～15.62%. The emodin and polydatin calculated with reference to the dried drug were 1.41%～2.25% and 1.37%～3.91%, respectively. It is proposed to contain less than 12.0% of moisture,5.0% of total ash and 1.0% of acid-insoluble ash, not less than 9.0% of extraction,1.10% of emodin,1.05% of polydatin. In order to evaluate the quality of Polygoni Cuspidati Rhizomaet Radix with high efficiency, an UPLC method with microwave was developed to measure the main five active compounds which are Emodin, Polydatin, Physicion, Resveratrol and Anthraglycoside B. The results demonstrated that the contents of the five components changed as the same tendency.Salvia miltiorrhizae Radix et Rhizoma is one component in Xiaoliu capsule, and Salvianolic acid B is the most constituent in water-soluble extraction of Salvia miltiorrhiza, it also has good activity. In Chinese Pharmacopoiea (version 2010), Its quantitative determination is Salvianolic acid B, so we need to control the content of Salvianolic acid B in Xiaoliu Capsule. This study established an HPLC determination method to measure the Salvianolic acid B in Xiaoliu Capsule. The calibration curve was good linear in the range from 0.0027 to 1.500mg/ml (r=0.9998). The average recovery and RSD were 96.50% and 2.59%, respectively. The contents of Salvianolic acid B in the 3 samples varied from 0.2522 to 0.2696mg/g. It is proposed to contain not less than 0.24mg/g of Salvianolic acid B in every Xiaoliu Capsule.