Preparation Of Compound Lycopene And Soybean Isoflavone Soft Capsule

Objective:TO develope a anti-oxidation product of lycopene and soy isoflavone for the middle-aged through preparation research,quality research,pharmacology and toxicology research.Methods:①Excipientes were selected by testing the compatibility with APIs,and its amount were optimized by orthogonal test,and obtained the better formulation.②To establish the critical process parameters about Colloid mill and Drying equipment.③For the validation of manufacturing process three batch samples were yieled in scale up 20 times amount of the prescribed.④Established anlytical methodes to study the production quality,and Compared with the reference preparation.⑤The rats were orally administered the sample in low dose,middle dose and high dose. The content of MDA and the activities of GSH-Px and SOD in serum were measured respectively.⑥Observed the quality of three batch preparations through the stability test according to Chinese Pharmacopoeia,and Confirmed the storage time.Results:①We choose Safflower Seed Oil as diluents. The preparation containes 1.5% beeswax as suspending agent,10.0% Caprylic Capric Triglyceride and 3.0% lecithin as dispering agent,1.2% Vitamin E and 0.015%TBHQ as antioxidant reagent.1.0% titanium dioxide used as a masking agent and 0.0015% rose pigment in the capsule shell.②The mixing time of the Colloid mill for the capsule content is 7 minutes,4 hours is necensarry to dry the soft capsules③The process parameters meet the requirements, The rate of finished product is over 96% in three batches of the production④The established analytical method meet with the methodological requirements,The product quality is better than the reference material⑤The soft capsules significantly increases the activity of GSH-Px and the concentration of MDA,it shows the preparation could increase antioxidative effect in aged rats⑥There are no significant changes in every observation item,The Product quality is stable and controllable within 24 months. Conclusions:The optimized prescription composition is stable,reasonable, quality controllable and available in industrialization. the preparation is superior to the reference production,Animal tests show that the product has anti-oxidation function, does not appear toxic side effects.