Study On Preparation Technology And Quality Control Of Rnufu Zhiyang Compound Liposomal Gel

Objective:To study preparation technology of runfu zhiyang compound liposomal gel,to establish the quality standard,and to inspect the stability of finished product, all of which provide evidences for next studying.Methods:1.Study on preparate technology:Prescription chinese medicine were extracted, purified and enriched into extructum; borneol liposomes was prepared by thin-film ultrasonic method; mixing raw materials, auxiliary materials and gel, the extructum was made into Runfu Zhiyang compound gel.2.Study on quality standards:(1) The Angelicae Sinensis Radix, Sophorae Flavescentis Radix, Carthami Flos and Polygoni Multiflori Radix Praeparata were identified by TLC.(2) The content of emodin and matrine were determined by HPLC.(3) According to China pharmacopoeia2010edition,The filling quantity difference, pH, particle size, microbial limit were determined. 3. Stability study:The method of room temperature sample observation was used to evaluate stability of finished product.4. The preliminary pharmacodynamics research:the transdermal experiment method was earried out on the finished product efficacy.Results:1. The optimized extraction technique for the Chinese medicine using water extraction was achieved by adding water12times,10times water as much as the herbalmeterial in amount,decoction for2.0h、1.5h,marinating0.5h and extraction twice2. The optimized extraction technique for the Chinese medicine using70%alcohol extraction was achieved by adding water10times,8times water as much as the herbalmeterial in amount,decoction for1.5h,1.0h,marinating0.5h and extraction twice.3. The optimized purification technique for the Chinese medicine using water extraction was70℃water,add14%B at first,keep10min,standing2h,then add7%A, keep10min,standing24h,medicine quantity:medicine liquid volume=1:5. 4. The optimized purification technique for the Chinese medicine using70%alcohol extraction was70℃water,add6%B at first, keep10min,standing2h,then add3%A, keep10min,standing24h.medicine quantity:medicine liquid volume=1:10.5. The optimized prepration technique of borneol liposomes was dichloromethane35ml,lecithin300.0mg,cholesterol50.0mg, borneol25.0mg,PBS20ml.6.The Runfu Zhiyang liposomal gel was brown gel.the surface was clean, delicate,no impurity.The shape and character of the Runfu Zhiyang liposomal gel were consistented with regulation in the national pharmacopoeia.7.The weight discrepancy. pH. particle size, microbial limit were in line with the specifications of national pharmacopoeia.8. Both the method of TLC and HPLC had high specificity.9. Three batches of samples were stored at room temperature. Each index of stability was consisted with the quality standard. 10. Transdermal experiments show that The Runfu Zhiyang compound liposomal gel dermis transmittance is good.Conclusions:The method for preparation technology of The Runfu Zhiyang liposomal gel is feasible,the detemination method is simple and easy to be operated. And the content of the emodin and matrine is stable. So the method could be used to control the quality standard of the Runfu Zhiyang liposomal gel.