Zuojinwan Ph-sensitive Self-tuning The Administration Of Gel Capsules,

ZuoJinWan prescription is used as the research object,combined the modern technology and the advantage of the drug delivery and the character of traditional Chinese medicine,the ZuoJinWan pH sensitive automatic gel-capsule was prepared to study whether the pH sensitive automatic drug delivery system is suitable to ZuoJinWan prescription or not.the study are based on the three items.The first,The stomach ulcer or duodenal ulcer occurred when the mucous membrane was destroyed as a result of the hydrochloric acid concentration in stomach change obviously,the second,The pH sensitive automatic drug delivery system is a intellectual drug delivery system which could control the drug release according to the pH information in vivo. the third,The Chinese traditional medicine is advantaged to cure the peptic ulcer.The mono-factor design and the orthogonal design are used in the study on extracted technology and prepared technology,the most optimal extracted technology of ZuoJinWan:Extracted the Evodia with 10 times Water,soaking 6 hours and then extracted 5.5 hour,collecting the volatile oil.then added the Coptis chinensis Franch according to the prescription,and 12 times 1%(v/v) hydrochloric acid solvent was added and extracted twice,the first time is 1.5 hours and the second is 1 hour.Putting the filtration together and condensing it to opposite density to 1.02(60℃).When the filtration cool to 60℃,centrifuged it in 3000r/min.Gather the clear supermatant liquid, then condensed it on reduced pressure conditions.Dried the condensed between 60℃～80℃.Crush the dried extracted to powder and screened by seven bugle sifter.Adding the volatile oil to the powder by alcohol method with the ratio 0.7%.according to the intermediate control standard,the concentration of berberine hydrochloride in the extracted must over 238mg/g dried extracted and rutacarpine is over 1.3mg/g.dried extracted.The best manufacture technology:adding 0.45g chitins,0.2g polyvinylpyrrolidone(pvp) in 35ml water which is 30℃,dispersing the mixture on vacuum conditions,then 2ml acetic acid(3mol/l) is added into the mixture and swelling it 6 hours underpressure.1.3g ZuoJinWan extracted powder and 3ml formaldehyde are added into the mixture when it become clear,the polygeline is prepared and cut into pieces which is 2mmx2mm in area after 8 hours,the polygel pieces are dried under the vacuum and the dried temperature is 50℃. the dried polygel granula is loaded into 0 bugle capsule after repaired by five sifter,then the ZuoJinWan pH sensitive automatic gel-capsule was prepared after packaged.The quality standard of ZuoJinWan pH sensitive automatic gel-capsule was carded out,the consequence showed that coptidis rhizome and fructus were found in the thin layer chromatography of ZuoJinWan pH sensitive automatic gel-capsule.The quantitative testing method of berberine hydrochloride and rutecarpine were carried out and so as the testing method of pH stimulated responsibility of ZuoJinWan pH sensitive automatic gel-capsule.According to the standard,the concentration of berberine hydrochloride must over 70mg in each capsule and rutecarpine is 0.35mg.Both of the berberine hydrochloride and rutecarpine total release in hydrochloric acid solution (pH=2) at the second hour must over 80%while in pH=3 must low 30%.The sample initial stability research results showed that the ZuoJinWan pH sensitive automatic gel-capsule was stable in three months at the room temperature.According to the results,the prepared technology of ZuoJinWan pH sensitive automatic gel-capsule is stable and reliable,the quality standard carded out could control the quality of ZuoJinWan pH sensitive automatic gel-capsule.The pH sensitive automatic drug delivery system has suitability in ZuoJinWan prescription.