Study On The Preparation Technology And Quality Standard Of Anshen Qubai Pills

The prescription of Anshen Qubai Pills are made from eleven traditional Chinese medicinal materials,which are formulated according to“Traditional Chinese medicine formulation”,It have the effects of Nourish the heart,calm the mind and invigorate the blood,and are a classic remedy for vitiligo.The pills are a dosage form modified by the traditional decoction,and have the advantages of low cost,simple preparation method,and convenient carrying.The study systematically research on the preparation process of Anshen Qubai Pills,at the same time the topic has determined the quailty standard and the stability of the pills.It can effectively improve the quality control level of Anshen Qubai pills.（1）Study on preparation technology of Anshen Qubai pills:The characteristics and texture of the eleven medicinal materials are investigated,the medicinal materials that are not suitable for pulverization are inspected by adding water and concentrating.Finally,the decoction process of Polygalae Radix,Ziziphi Spinosae Semen,Acanthopanacix Senticosi Radix et Rhizoma Seu Caulis,Schisanrae Chinensis Fructus,Paeoniae Radix Alba,and Sappan Lignum are determined as follows:decoction twice,12 times water for the first time,10 times water for the second time,each for 1 h,concentrated to a density of approximately 1.15 g/cm³.Polygoni Multiflori Caulis,Cyperi Rhizoma,Salviae Miltiorrhizae Radix Et Rhizoma,Spatholobi Caulis,and Glycyrrhizae Radix et Rhizoma are crushed.By examining the degree of crushing and the yield of powder,it is determined that the powder was passed through a 100-mesh sieve and panned with the medicinal solution to make a final sample.（2）Study on the standard of Anshen Qubai pills:1)Identification research:Based on the thin-layer identification study of Anshen Qubai Pills,a thin-layer identification method of Polygoni Multiflori Caulis,Acanthopanacix Senticosi Radix et Rhizoma Seu Caulis,Salviae Miltiorrhizae Radix et Rhizoma,Cyperi Rhizoma and Sappan Lignum are established.The durability of the method is investigated,and the results show that the method has good durability,specificity and reproducibility.2)Research on determination of content:With reference to the quality standard of Polygoni Multiflori Caulis in the 2015of the Chinese Pharmacopoeia,the content determination of Polygala tenuifolia saponins is studied,the extraction method is:ultrasonic extraction with 70%methanol for 30 min.Chromatographic conditions:Kromasil 100-5-C₁₈（4.6×150 mm,5μm）column;Mobile phase:methanol-0.05%phosphoric acid（70:30）;Detection wavelength:210 nm;Flow rate:1.0 m L·min^-1;Injection volume:10μL;Column temperature:30℃.Study on the determination of PolygalanthoneⅢand 3,6’-dinadicyl sucrose,the extraction method is:70%methanol reflux extraction for 90 min.Chromatographic conditions:Kromasil100-5-C₁₈（4.6×150 mm,5μm）column;Mobile phase:acetonitrile-0.05%phosphoric acid（18:82）;Detection wavelength:320 nm;Flow rate:1.0 m L·min^-1;Injection volume:10μL;Column temperature:30℃.The methodological research results show that the method established is efficient,accurate,high precision,good specificity and reproducibility,which provides an effective basis for the research and establishment of quality standards for Anshen Qubai Pills.（3）Study on the stability of Anshen Qubai pills:The accelerated and long-term temperature stability tests of Anshen Qubai Pills are examined,and the results show that the pills are stable within one year,providing a theoretical basis for clinical application.