Preparation And Evaluation Of Cangzhuyou Soft Shell Capsule

Objective: to study the making of soft shell Capsule of volatile oil from atractylodes.Method: The extraction technology of atractylodes volatile oil is optimized by means of U-design according to the content of volatile oil. The new processed drugs suiting to atractylodes oil are compared. Taking disintegrating time of soft shell Capsule as a index, the prescription of capsule materials is optimized using U-design. The ratio between volatile oil and adjuncts is selected by studying the drying time according to disintegrating time and water content of capsule. The major constitions of volatile oil are analysed using gas chromatography-mass spectrometry. The quality standard of volatile oil are worked out in accordance with the character of volatile oil and the requestion of new drug. TLC identification is carried out using ft -eudesmol as a contrast. The content of ft -eudesmol is determinated in both preparation and volatile oil using GC in accordance with internal standard-pentadecanol. The quality standard is laid down and the effection and securation of the drug are explored.Result: The [optimal extraction technology of volatile oil is that herb is immersed 2h with 4 times water first and then extracted for 7h.The optimal ratio of glutin, glycerin and water is 2:1 ;1 and ratio of volatile oil to salad oil is 1:1.Capsule should be cooled and fixed for more that 4h and dried 12-15h at 30-35 癈 .TLC identification has high speciality. Its average percent recovery is 99.60 and RSD is 1.30 percent. Gang zhuyou soft capsule has the effect in protection and treatment of aged rarefaction of bone and is safe. Conclusion: The method of productive technology and quality control is simple, feasible and stable. Pharmacodynamics test and security appreciation have provide a tested foundation to clinical practice.