Study On The Preparation Technology And Quality Standard Of Tang Ganjian Concentrated Pill

Objiective: "TGJ Decoction" is composed of 9 herbs,such as Paeonia lactiflora Pal L,Angelica sinensis(Oliv.)Diels and Poria cocos(Schw.)Wolf,the prescription is a experienced prescription obtained by clinical departments of Wuhan Hospital of Traditional Chinese Medicine through long-term clinical experience.Due to the traditional decoction exists a certain convenience for patients,in order to meet the needs of patients with medication better,improve the drug efficacy,reduce the dosage,make it more convenient for patients to carry,so we develop a systemic preparation and develop it into the new preparation concentrated pill.The pill is a combining product combined by modern development technology and traditional Chinese medicine,it not only embodies the advancement of modern pharmaceutical technology,but also keeps the advantages of traditional decoction,which is consistent with the characteristics of traditional Chinese medicine,and is suitable for mechanized production,saving a lot of excipients.The purpose of this study is to optimize the preparation technology of Tang Ganjian concentrated pill,and to establish the quality standard,in order to develop a Tang Ganjian concentrated pill which is safe,effective and has stable quality.Methods:(1)the study of preparation technology: in order to determine the technological parameters of the water extraction of the concentrated pill,the L9(34)orthogonal test was investigated on extraction time and extraction timesand the amount of water.Because the Paeonia lactiflora Pal L and Angelica sinensis(Oliv.)Diels are the monarch drug in a prescription,paeoniflorin is one of the main active ingredients of Paeonia lactiflora Pal L,ferulic acid is also one of main active ingredients of Angelica sinensis(Oliv.)Diels,so this paper selected the content of paeoniflorin and ferulic acid and extract yield as indexes,to optimize the best extraction process parameters.The content of paeoniflorin and ferulic acid were determined by HPLC chromatographic,conditions: column: Wonda Sil C18(250mm x 4.6mm,5 m);mobile phase:acetonitrile-0.1% phosphoric acid(16:84);flow rate: 1m L/min;column temperature: 30 C;detection wavelength: 230 nm.(2)Study on quality standard: in order to control the production quality of Tang Ganjian concentrated pill,the TLC was used to indentify Angelica sinensis(Oliv.)Diels,Atractylodes macrocephala Koidz and Polygonum cuspidatum Sieb.et Zucc,Coptis chinensis Franch,Bupleurum chinense DC and Artemisia scoparia Waldst.et Kit.Poria cocos(Schw.)Wolf and Schisandra chinensis(Turcz.)Baill was indentified by microscopic identification method;HPLC chromatographic was used to determine the content of paeoniflorin and ferulic acid,chromatographic condition: chromatographic column: Wonda Sil C18(250mmx4.6mm,5 m);mobile phase: acetonitrile-0.1% phosphoric acid solution;gradient elution;flow rate: 1m L/min;column temperature: 35 C;detection wavelength: 230 nm and 316 nm.(3)The study of fingerprint HPLC : HPLCwas used to analyze and study the“Tang Ganjian concentrated pill”,and to establish the fingerprint of HPLC,which can be used to control its quality.Chromatographic condition:chromatographic column: Wonda Sil C18(250mmx4.6mm,5 m);mobile phase: acetonitrile-0.1% phosphoric acid solution;gradient elution;flow rate:1m L/min;column temperature: 35 C;detection wavelength: 230 nm,using chromatographic fingerprint similarity evaluation software to evaluate theresults;Results:(1)the optimum extraction process was 10 times the amount of water,extracted for 3 times,each time 1h.(2)TLC methods can be used to indentify Angelica sinensis(Oliv.)Diels,Atractylodes macrocephala Koidz and Polygonum cuspidatum Sieb.et Zucc,Coptis chinensis Franch,Bupleurum chinense DC and Artemisia scoparia Waldst.et Kit.Microcopical indentification can be used to indentify Poria cocos(Schw.)Wolf and Schisandra chinensis(Turcz.)Baill.Under the chromatographic conditions,paeoniflorin and ferulic acid showed a good linear relationship in the range of0.1925~3.85?g and 0.04~0.80?g,The average recovery rate of paeoniflorin and ferulic acid were100.7% and 99.7%,RSD were0.87% and0.67%(n=6).The similarity of the ten batches of samples is greater than 0.99,which indicates that the product quality is stable.Conclusion: the optimized extraction technology is reasonable,stable and feasible,providing experimental basis for TGJ pill extraction process,and the quality standard method is simple and reliable,strong specificity,good repeatability,and can effectively control the quality of the preparation.At the same time,the HPLC fingerprint technology is fast,convenient,stable and reliable,and can effectively monitor the quality of the Tang Ganjian concentrated pill.