Study On Preparation Process And Quality Standard Of Shuang Shen Ping Fei Granules

In recent years,with the rapid development of the economy,the urban air pollution aggravated,leading to the sharp decrease in air quality.Sewage,automobile exhaust,haze will undoubtedly accelerate the pace of deterioration of the ecological environment and affect the human respiratory system seriously.Therefore,there is a high incidence of lung diseases in the modern society.Shuangshen Pingfei Granule is formed by the clinical experience for the treatment of pulmonary arthralgia and composed of ginseng,salvia,rhizoma anemarrhenae,Radix Asparagi,dried tangerine peel,Cortex Lycii,cortex mori radicis and radix glycyrrhizae.It was made into granule which has an effect of clearing lung-heat and moistening dryness and downbear counterflow and check vomiting.It is used for the cough,phlegm and distention and fullness.This paper systematically reviewed the process and quality standard of Shuangshen Pingfei Granule.This thesis consists of five parts:Part Ⅰ:Literature Review:The prescription solution,chemical compositions of prescription drug and pharmacological effects of Shuangshen Pingfei Granule are introduced.Part Ⅱ:Study on Preparation process:Using the water extraction and alcohol extraction which are optimum for industrial production.Selecting the content of salvianolic acid B as index compents and choosing alcohol extraction technique for ginseng and Salvia miltiorrhiza by orthogonal test,the orthogonal method was used to optimize the extraction technology of ginseng and ginseng;The content of Mangiferin as indices,the extraction process was optimized according to the rule of complex prescription;the glycyrrhizic acid content as indices and choosing water extraction technique for cortex mori radicis,Radix Asparagi,dried tangerine peel,Cortex Lycii and radix glycyrrhizae by orthogonal test.In the study of the preparation process of Shuangshen Pingfei Granule,it was found that mangiferin in Anemarrhena may reduce the transfer rate because of the form of association from Morus alba L.and Rhizomav Anemarrhenae.Therefore,the best extraction methods were as follow:take ginseng and salvia,the material liquid ratio was 1:6 and 1:5 with 70%ethanol as the extraction solvent,extract twice with 1.5h each time,filter the ethanol extraction,recover ethanol,concentrate and spare.Take Rhizoma anemarrhenae slices,add 10,8 times the amount of water,extract twice with 1.5h each time,fliter and merger;take ginseng,Salvia miltiorrhiza and other five herbs,add 10,8 times the amount of water to extract 2 times.each 1.5h,filter,combine with the Rhizoma anemarrhenae extraction.Mix the above alcohol concentration,concentrate to a relative density of 1.16 to 1.28(50℃).Take dextrin,spray drying and granulate with aspartame.PartⅢ:Study on quality standard:Shuangshen Pingfei Granule is a new drug and is lack of relevant quality standards research.The main components of mangiferin and salvianolic acid B were used for the determination and each drug thin layer identification method was preferred,the chromatographic conditions were:mobile phase was acetonitrile(A)-0.1%trifluoroacetic acid(B)at gradient elution program;detection wavelength:245nm;column temperature:30℃.The method is simple,specific and reproducible for the determination of salvianolic acid B and mangiferin.PartIV:Preliminary study on stability:The results showed that the quality of the product was stable,safe and reliable.Part V:A Preliminary Study on Traceability of Shuangshen Pingfei Granule Based on LC-MS-MS:The samples were extracted with methanol and chose methanol-acid system as the mobile phase.21 peaks were selected.The experiments show that the fingerprint method has good reproducibility and stability.The similarity analysis of different batches of samples was carried out by using the similarity evaluation system of traditional Chinese medicine fingerprints.The results showed that the samples were 0.95 or more which indicated that the process was stable.After HPLC-DAD was used to detect the samples,21 common peaks were assigned to herbs,and the components were identified by HPLC-MS.The 31 components were found in the preparations and the herbs.Conclusions:The researches of technology,quality standards,stability,experimental study,traceability research,etc incidate that the process is reasonable,the quality standard is feasible and the prepared samples are stable.