Study On Gynostemma Pentaphyllum Dispensing Granule And Its Quality Standard

Gynostemma pentaphyllum is a medicinal and edible food with the similar function as ginseng’s.Its main pharmacological ingredients are Gypenosides which have functions on immune modulation,anti-cancer,anti-oxidation,hypolipidemic and so on.It can be used in the treatment of hypertension,hyperglycemia,hyperlipidemia,fatty liver and other diseases.The dispensing granules of traditional Chinese medicine(TCM)are modern dosage forms of TCM,which are prepared fromthe TCM through multiple process including water extraction,concentration,drying,granulation and so on.They can be directly used in clinical prescriptions and have many advantages such as easy to take,precise,easy to carry,hygienic and so on.In this study,we collected 16 batches of Gynostemma pentaphyllum produced from different areas,and did the studies on the standard decoction,HPLC fingerprint,water extraction,granule preparation,pilot scale-up and quality standard of the granule.The research methods and results are as follows:(1)Study on the standard decoction of Gynostemma pentaphyllumWe collected 16 batches of Gynostemma pentaphyllum which were in line with the Ministry-promulgated Standards.They were prepared as standard decoctions which were further determined with yield rate,the content of flavonoids and saponin.The results showed that the content range of Gynostemma pentaphyllum flavonoid is 3.42 ～ 8.08 mg/g,the average content is 6.27±1.34 mg/g,and of Gynostemma pentaphyllum saponin is 1.97～6.44 mg/g,the average content is 3.25±1.51 mg/g;and the Gynostemma pentaphyllum yield rate ranges from 10.23% to 19.69% with the average at 16.88%±2.17%.(2)Study on HPLC fingerprint for the standard decoction of Gynostemma pentaphyllum。The HPLC fingerprint was established for standard decoctions made from 16 batches of Gynostemma pentaphyllum.There were 7 peaks in common.The content of the seven peaks were very variable in Gynostemma pentaphyllum collected from different areas.(3)Study on the preparation of dispensing granules of Gynostemma pentaphyllumWater was used to extract Gynostemma pentaphyllum.The optimization was focused on Gynostemma pentaphyllum extraction time,the number of Gynostemma pentaphyllum extractions and the amount of Gynostemma pentaphyllum extraction water added.The investigations were focused on the Gynostemma pentaphyllum yield rate,the concentration of Gynostemma pentaphyllum flavonoids and Gynostemmapentaphyllum saponin.The samples preparation was based onthe orthogonal experiments.The optimized method was: the Gynostemma pentaphyllum was added with 15-fold of water,soaked for 1 h,and followed by being boiled for 1 hour.The residues were boiled twice for 1 hour in each in 12-fold of water.The Gynostemma pentaphyllum filtrates were concentrated at 60 ℃ under reduced pressure and the Gynostemma pentaphyllum extract were obtained with a relative density of 1.05 to 1.15.The pilot scale-up study was performed on the method and the extracts were spray dried.The dispensing granules were made from the mixture of dried powder: dextrin: crospovidone(50:4:1).(4)Study on quality standard and stability for the dispensing granules of Gynostemma pentaphyllumUsing the three batches of granules,the quality standard of Gynostemma pentaphyllum granules was preliminarily established based on the edition of Ministry-issued Standards for Gynostemma pentaphyllum and of “Chinese Pharmacopoeia”for general requirements of granules.The stability study was performed and the quality showed dispensing granules of Gynostemma pentaphyllum stable under the packaging conditions.