Studies On Preparation Process And Quality Standard Of Xuejie Ruansun Capsules

Xuejie Ruansun Capsules is a new compound preparation of pure Traditional Chinese Medicine, which consists of Panax notoginseng,Resina draconis, Chinese Angelica, Corydalis, Amur Corktree Bark, Divaricate Saposhnikovia Root.The prescription has been used clinically for many years. Xuejie Ruansun Capsules has the function of invigorating the circulation of blood and removing blood stasis, reducing swelling and alleviating pain.It is used for hemostasis swelling pain and all kinds of local soft tissue injury caused by traumatic injury in clinic.According to Chinese medicine,natural medicine new drug registration requirements of category 6.1, the preparation process and quality standard of Xuejie Ruansun Capsules are studied experimentally on system by applying modern science and technology, with the guidance of traditional Chinese Medicine theory, to ensure the scientific and reasonable preparation process and the quality is stable and controllable 1.Study on preparation processThe extraction process: with the dry extract yield and the transfer rate of the main effective components: PNS Panax Notoginseng Saponins, Ferulic Acid, Tetrahydropalmatine, Phellodendrine, Prim-O-glucosylcimifugin and 5-O-methylvisammioside as the evaluation index, through preliminary test and orthogonal design expriment, then combined with the pharmacodynamic test results, ultimately we determine the extraction process of Xuejie Ruansun Capsules as follows: Panax notoginseng,Resina draconis, Chinese Angelica, Corydalis, Amur Corktree Bark, Divaricate Saposhnikovia Root, added 10 times amount of 60% ethanol and extracted for 2 times, 1.5 hours each time, the extracted liquid was filtered, then the filtrate was combined,spare.Contentration and drying process: With the transfer of PNS Panax Notoginseng Saponins rate as evaluation indicator, through the investigation of concentration and drying methods and temperature, Ethanol extract after the merger was concentrated under reduced pressure to paste with relative density of 1.26(60℃) and joined the Resina draconis powder,vacuum drying into dry extract under 80℃.The Prepation Process: By investing the influence of different excipients, wetting agent and the consumption on the granulation, using many experiment study, then determine the forming process of Xuejie Ruansun Capsules: the dry paste powder(80mesh) and Starch(11:4) was mixed, then added the appropriate amount of water, made into soft material, palletized by 20 mesh, dried, sieved by 18 mesh,blending,filled into the capsule,aluminum-plastic packed,namely. 2.Study on quality standardStudy on TLC identification: TLC was adopted for the identification of Panax notoginseng,Resina draconis,Corydalis,Amur Corktree Bark in Xuejie Ruansun Capsules. The results show that the sample displays the same spots with control drug or control in the corresponding position, and has no negative interference.Study on content of HPLC determination: The content of PNS Panax Notoginseng Saponins, which exists in Panax notoginseng of Xuejie Ruansun Capsules was determined by HPLC. The chromatographic conditions are as follows: Eighteen alkyl silane bonded silica as filling agent; Acetonitrile-water(1-12 minutes: 19:81, 12-60 minutes: 19â†'36:81â†'64) as mobile phase; detection wavelength is 203nm; column temperature is 30℃; flow rate is 1ml/min. Through the ten batch of pilot and the three batch of pilot study to determine the content of tetrahydropalmatine in the finished product, that is not less than 6.3mg in each capsule.