Study On The New Slow-release Of Erhuang Double-layered Suppository

Objectives:This experiment is based on taking the old Chinese national with outstanding students,professors,Heilongjiang Province,Chinese medicine practitioners Wang Xiuxia of Heilongjiang University of Chinese Medicine,summary in the long-term clinical practice derives from the effective prescription-ERHUANG power developed into new slow-release double bolt suppository.Method:In the research group has established a foundation for ERHUANG double-bolt forming new slow-release pre-treatment methods,the first were established double new slow-release suppositories berberine alkaloids and polyphenols ERHUANG ingredient HPLC analysis methods,and the outer layer to berberine Hydrochloride as an indicator,the inner catechu catechin as an index to establish the new measurement method ERHUANG slow release double yellow bolt vitro release,By examining the release medium,wrapping materials,the release medium volume,the impact of speed on the release,the measurement method to determine the in vitro release rate;Furthermore,the three time points,respectively,to release as assessment indicators,orthogonal experimental design to optimize the formulation and preparation of ERHUANG tied controlled release of the double outer and inner layers,drawing release curve,release model analysis;Then follow the "Chinese Pharmacopoeia"(2010 edition)under the provisions of Appendix IW suppositories term,controlled release of the children of new double tied yellow appearance,weight variation,pH,etc.to inspect,using the TLC method suppositories berberine and catechu be qualitative identification,HPLC method for berberine berberine hydrochloride,palmatine hydrochloride,coptisine table berberine and catechu catechin and epicatechin conduct determination and release study.Results:HPLC analysis of berberine alkaloids and catechu established in this paper are:alkaloid berberine acetonitrile:0.05mol· L-1 potassium dihydrogen phosphate(50:50)(per 100mL adding SDS-Na 0,4g,then phosphate adjusted to pH 4.0)as the mobile phase,detection wavelength was 345 nm,the flow rate was 1mL · min-1,measured at 30? under the conditions.Catechu methanol:0.04mol ·L-1 citric acid:N,N-dimethylformamide-tetrahydrofuran(45:8:2),the volume ratio(15:85,V/V),column temperature 35 ?;detection wavelength was 280 nm;flow rate was measured at 1 mL · min-1 condition.Determination of release rate of 500 mL,0.1 mol · L-1 HCL solution for the release medium,wrapping material is porous membrane,speed is 100 rpm;optimal prescribing controlled release new double yellow children tied to the outer HPMC:PEG4000:PEG400 =0.07:10:4,inner HPMC:PEG4000:PEG400?0.2:10:4;optimum process for the preparation of both temperature and mold preheating temperature 70?,stripping time 30min;Quality Standards ERHUANG tied yellow new slow-release double orange for outer and inner brown,smooth,smooth,firm junction,inner and outer layers of uniform color.The average weight of each chop bolt 2.0264 ± 0.0464.pH was 6.73.By TLC method of double bolt in berberine and catechu qualitative identification,test results showed the same size and reference spots,consistent position,negative interference.The detachment double tied with berberine berberine hydrochloride,palmatine,berberine coptisine and tables shall not be less than 1.92mg,0.236mg,0.329mg and 0.282mg,catechin and tables containing catechu shall not be less than the total amount of catechins 6.2mg;release inspection standard;showed children tied yellow double by new slow-release drug delivery model to analyze compliance with the principles of slow-release formulation of the "2010" version of the Pharmacopoeia.Conclusion:The ERHUANG slow-release preparation of this paper bunk established stable and feasible,Good prescription optimization,technology leadership and tradition,scientific and standardized preparation,In the release conditions of exploration for suppositories is an innovation in a simulated environment cavity prerequisite for the validity of this method high repetition rate.