Soft Capsules Of The Compound Gamma-linolenic Acid Developed

Objective: This topic becomes the compound prescriptionγ- linolenic acid lipin system the soft capsule, enhancesγ- the linolenic acid stability; facilitates the clinical use.Mainly completes the preparation prescription composition and the craft research, the quality specification research and the preliminary stable inspection.Methods:(1)By malondialdehyde(Mna) is the target, the screening oxidation inhibitor Vit-E amount used.(2) dissolves the speed take the lemon yellow as the indicator determination pouch skin, uses the single factor experiment design and the even experimental design optimal soft capsule pouch skin prescription .(3) determines the soybean phosphatide with the HPLC method principal constituent phosphatide tai choline (PC), the phospho-lipin tai ethyl alcohol (PE).(4) with the single factor and the orthogonal testing method to the ganoderma lucidum polysaccharide extraction screen optimized craft. (5) acts according to the quality control request establishment compound prescriptionγ- flax worn out and aching capsule the quality specification .(6) acts according to the Chinese pharmacopoeia 2005 edition medicine stability test guiding principle, carries on the acceleration test and the ng-term test.Results: (1)Oxidation inhibitor Vit-E (content)70% the amount used is6%. (2)Optimal publishes the rubber prescription: Glycerine: Gelatin=1:0.847, PEG400: Gelatin =1:0.0586, The amount of TiO₂ used dissolves the speed in the between 0.3%～4.0%to the pouch skin not to have the influence.(3) Determines the soybean phosphatide with the HPLC method principal constituent phosphatide tai choline (PC), the phospho-lipin tai ethyl alcohol(PE). The ancient Chinese medical classics legal science confirmation, determined examination method stable reliable, the reproduction quality is good.(4) The ganoderma lucidum polysaccharide best extraction craft is: decoction fluid pH 11, for the first time 120min,the decoction time compares 3.0: 2.0: 0.5 , Adds the liquid volume is 8 times.(5) The establishment quality specification may monitor the soft capsule effectively andγ-the linolenic acid quality.(6) The preliminary stability test each inspection target has not seen the obvious change.Conclusion:(1) The optimized prescription composition is reasonable, the craft is stable.Available in industrialization production .(2) the quality specification is feasible, preparation quality controllable.(3) the preparation preliminary stability is good, has made the new attempt in the solution lipin body stable aspect.(4) Enhanced ganoderma lucidum polysaccharide extraction efficiency.(5) Increasedγ-linolenic acid stability, increasemedicament quality.