Prepared the compound recipe of Xiong Dan in Situ Forming System for OcularDrug Delivery according to the technical methods of innovative drug research oftraditional Chinese medicine and requirements, which the effect is Qingrejiedu andwas used in the treatment of acute and chronic catarrhal conjunctivitis, epidemickeratitis.According to the technical requirements of research and development of new drugof TCM, the study of "bear bile is a type of gel formulation, preparation technology andquality standard and so on has carried on the experimental study of science. In the studyof extraction process, according to the nature of the prescription drugs in the waterextract-alcohol precipitation in the method to extract the effective ingredient in bear bilepowder; In preparation for molding process, compares the pH sensitive type,temperature sensitive type, ion sensitive type three eye ophthalmic gel type, meshoptimization through the experiment, the best accessories kinds and dosage, to deter-mine the molding process; In the study of preparation of quality standard, by using bearbile powder has carried on the qualitative identification method of TLC, HPLC methodis used to mensurate the content of sodium tauroursodeoxycholic acid in thepreparation,established quality standards;Optimum extraction process of bear bile powder as the following: Prescriptions ofbear bile powder and injection water,100ml, heat to boil for10minutes to dissolve,put the cold, and alcohol content of75%ethanol, let stand for24hours, filtration, thefiltrate vacuum recycled ethanol, quick; Molding process finalized in0.5%0.5%ofgellan gum, sodium hyaluronate as gel base, type of bear bile eye ophthalmic gelpreparation, residence time than "bear bile eye drops significantly extend; The qualitystandard research results show that the bear bile powder samples to oxygen with cowsulfonated bear bile acid sodium reference substance have corresponding spots, HPLCdetermination of bovine sulfonated bear in preparation to oxygen content of cholic acidsodium, content determination method of high sensitivity, high precision, good stability.Preparation of cattle sulfonated bears to the oxygen content of cholic acid is not lessthan1mg/g.Type through the experimental investigation, the bear bile eye ophthalmic gel hasgood formability and delay the drug release effect, established the quality control method of science, good reproducibility. |