Pharmaceutical Research Changning Dropping Pills

To aim at ulcerative colitis(UC),according to the clinic use and character of Chinese medicine,choosing Periplaneta Americana which has significant curative effect in clinic of UC,with its main component(component protein) easily destroyed in protein and to give only by clysters as research object,prepare it as ChangNing colon delivery praeparatum for oral use,and research the quality standard of half-finished product,,exterior and interior evaluation and quality standard etc.The main contents include:By studying the medical material resource,character,TLC and assaying,build up the qualitation and quantitation of half-finished product.Choose half-finished product with more oil components to prepare dripping pills,then coating colon-dissolving material to achieve the purpose of delivery dispelling in colon.In the artwork research of dripping pills,apply mon-factor investigation to find out the kind of base material,the ratio of base material and medicine,the temperature of dosage liquor,the kind of condensing agent,the temperature of condensing agent,the dripping distance and speed etc.Further more,chose the ratio of base material and medicine,the temperature of dosage liquor and the dripping speed which have larger influence factors,with better indexes as research levels to decide the forming artwork of dripping pills with orthogonal experiment.In the research of coating artwork, referring CODES^TM colon dispelling design of western medicine,apply pH-enzyme relying association leechdom mechanism and multi-coating technology,settle the coating artwork as:(from inside to outside)heart of dripping pill,sugarcoating,enteric coating,isolation gown,acid-dissolving coating.With the evaluation of vitro-delivery, decide the coating artwork of dripping pill.Observing the dripping pills under sweep electron microscope,research the dispelling mechanism of medicine,and the experiment shows that the dispelling of the dripping pills is identical with the design.In the research of vitro-dispelling degrees of praeparatum,the result shows that it won't dispel in stomach and almost won't leak out in small intestine(61%),however, it dispels 48.7%within 0.5 hours in zymo- intestinal juice,and 86.5%in 1 hour with obviously sudden dispelling process,and in 2 hours,totally dispelling.The results also show that the multi-coating dripping pills has excellent locating disposition of colon in body.Using X ray Baso₄ visualization to study the dispelling proceeding of multi-coating dripping pills in human bodies,study found that the coating dripping pills can pass the stomach and keep shape in small intestine;the disaggregation of coat almost happens at AC and colon transversum.So the coating dripping pills have good location effect in colon.Build TLC to examine the relative substances and apply the absorption spectrometry and amino acids auto-measuring to assay content,and define the quantitation standard.