Study On The Substance Benchmarks Of The Classic Formula Ganjiang Lingzhu Decoction

Objective: In accordance with the principle of decoction of ancient traditional decoction,the traditional medicinal materials in the classic famous prescription "Ganjiang Lingzhu decoction" were verified and the base source was determined,the decoction method was studied,the quality standard and standard operating rules were established,the quantity transfer from the decoction pieces to the corresponding objects was studied,which makes the use of classical formula more standardized,and the standard of modern traditional Chinese medicine preparation was reached,which provided the basis for classical formula to play the curative effect better.Methods: According to the ancient records,the medicinal materials in the classic famula prescription "Ganjiang Lingzhu decoction" were verified and the base source was determined.According to the method recorded by the prescription,the preparation process was determined.Each flavour of a drug was selected from 15 batches of different origin,randomly matched and decocted,and 15 batches were prepared.According to the 2015 edition of Chinese Pharmacopoeia,it was studied by TLC and HPLC,and the method of TLC identification,content determination,fingerprint was established,and the quality standard was established.Results: The preparation technology and quality standard were included in the experimental study of substance reference of Ganjiang Lingzhu decoction.On the preparation process: According to the prescription of Ganjiang Lingzhu decoction,the prescription was soaked in purified water for 1000 mL for 30 minutes,open fire heating,high heating about 10 minutes,slow heating about 20 minutes,nylon cloth filtered filtrate600 mL,freeze-drying.As to the quality standard: TLC method of Glycyrrhiza Radix Et Rhizomz and Zingiberis Rhizoma was established,and the precision,repeatability and stability of HPLC content determination and fingerprint determination methods were established.Using glycyrrhizin as the reference peak in the corresponding physical fingerprint,15 common peaks were determined,and the No.4 peak was identified by thecomparison of reference substance which is glycyrrhizin,No.13 is glycyrrhizin acid,No.14 is6-gingerol.The similarity between the corresponding physical fingerprint and the control fingerprint is better than 0.9.Average contents of glycyrrhizin,glycyrrhizic acid and6-gingerol were 24.5 mg/g、35.6mg/g、1.6mg/g.The average transfer rates of glycyrrhizin,glycyrrhizic acid and 6-gingeroL were 70.65%,43.79% and 7.70%.The average discharge rate of 15 batches of substance was 12.33%.The average moisture content of the object is9.03%.Conclusion: On the basis of the ancient method as far as possible,the preparation technology of the classic formula Ganjiang Lingzhu decoction can be used to prepare the corresponding material of Ganjiang Lingzhu decoction more stably;Using TLC to study and establish the identification method of Glycyrrhiza Radix Et Rhizomz and Zingiberis Rhizoma,it can identify the material reference of Ganjiang Lingzhu decoction well,and negative without interference;Using high performance liquid chromatography,using glycyrrhizin,glycyrrhizic acid and 6-gingerol as control,the method of content determination and fingerprinting was studied and established.The method is simple,accurate and reliable,and can be used to control the quality of substance reference of Ganjiang LingZhu decoction.According to the 15 batches,the average content,average transfer rate,extract quantity and moisture content of glycyrrhizin,glycyrrhizic acid,6-gingeroL showed discrete data(70%~130%).The tentative ranges of glycyrrhizin,glycyrrhizic acid,6-gingerol were 17.1~31.8mg/g、24.9~46.3mg/g、1.1~2.1mg/g respectively.The tentative transfer rates of glycyrrhizin,glycyrrhizic acid and 6-gingerol ranged from49.46~91.85%,30.65~56.93%,5.39~10.01% respectively.The tentative ranges out of the paste rate range of 8.63~16.02%.The tentative ranges of moisture content range is6.32~11.74%.