Pharmaceutical Study Of Yiqirunchangtongbian Granules

The Yiqi Runchang Tongbian granule originated from clinical effective prescription which is composed of Astragali Radix,Atractylodes macrocephala Rhizoma,Cistanches caulis carnosus,Cannabis Fructus,aurantii Fructus,Liushenqu,Cinnamomi Cortex.It has the function of fortify the spleen and supplement qi,moistening intestines to relieve constipation.It has been used in the treatment of spleen qi deficiency syndrome of function constipation.It is suitable for habitual constipation,colon transport slow and the elderly,postpartum blood deficiency of constipation.According to the requirements of Drug Registration of CFDA,the study mainly on pharmaceutical Study of Yiqi Runchang Tongbian granule.Study on material:Astragali Radix,Atractylodes macrocephala Rhizoma,Cistanches Herba,Cannabis Fructus,aurantii Fructus,Cinnamomi Cortiex were detected according to the relevant provisions of the Chinese Pharmacopoeia(edition 2010,part ?).And according to"Henan Chinese Herbal Pieces cooked norms"(edition 2005)to identify Liushenqu.The results met the requirements and can be used in pharmaceutical research of Yiqi Runchang Tongbian Keli.Study on preparation process:Based on document and the physical and chemical properties of the active ingredients,we have developed a process route.1.We chose the volume of volatile oil as the index,and using single factor test to compare different granularity on the impact of volatile oil extraction.We decided to adopt coarse powder to extract.Then the orthogonal test was adopted to optimize the extraction process of volatile oil of Atractylodes macrocephala Rhizoma,aurantii Fructus,Cinnamomi Cortiex.The optimized conditions are soak for 1 hours with 6 times the amount of water and distilling for 7 hours.And the optimum extraction process of volatile oil was verified.2.Orthogonal design was used with yield of inclusion compound,the inclusion rate of volatile oil,oil in inclusion compound as indexes to optimize the inclusion process of volatile oil.The optimized resultes are volatile oil and ?-CD ratio of 1:6,grinding 90min with 4 times the amount of water.And the optimum inclusion process of volatile oil was verified.3.The content of Astragaloside ?,Calycosin-7-glucoside and extract yield was used as indexes to optimize the alcohol extraction process of Astragali Radix and Cannabis Fructus.The result is adding twelve times amount of 60%alcohol and extracting for 2 h(totally extracting for 2 times).And the optimum alcohol extraction process was verified.4.The water extraction process of Cistanches Herba,Liushenqu and foregoing the dregs were optimized by orthogonal experiment with the contents of echinacoside,acteoside,polysaccharide and the yield of water extract used as indexes.The optimum one is extracting 2 times with twenty times amount of water and extracting for 1.5 h.And the optimum alcohol extraction process was verified.5 Water extractions and alcohol sedimentation technique was adopted to determine the best purification process.The result is added to 50%alcohol content for the better.6 Concentration and drying process were using concentrated under reduced pressure,vacuum drying respectively.Preferably optimum process:alcohol deposit fluid,alcohol extract fluid were recovered ethanol,and then merged.Concentrated to extractum at 60 ?,0.09 mpa,and at 70 ?,0.09 mpa dried to powdered extract.7.Preparation process:powdered extract:powdered sugar:dextrin:micronization silica gel=1:0.3:0.7:0.05.8.The results of three batches of pilot scale test showed that the transfer rate of echinacoside,acteoside,and Calycosin-7-glucoside were both greater than 50%,the process was stable and feasible.Study on quality standard:Identifications of Astragali Radix,Atractylodes macrocephala Rhizoma,Cistanches Herba,Cannabis Fructus,aurantii Fructus carried out by TLC.The results showed that feature were clear and negative without interference and good reproducibility.According to Chinese Pharmacopoeia(2010 Edition,Part I,Appendix I C)under the relevant provisions of sample granularity,moisture content,dissolubility,content uniformity,microbial limits were examined,results are in line with the requirements.Determination of echinacoside,acteoside content and calycosin-7-glucoside content by HPLC method in preparation.The results of methodological study showed that the linear ranges of echinacoside,acteosid,calycosin-7-glucoside,were 19.5?117.0?g/ml,3.1?18.7?g/ml,4.3?25.9?g/ml.The average recovery rates(n=6)of echinacoside,acteosid were 98.97%,the average recovery rates(n=6)of calycosin-7-glucoside were 98.84%.According to the determination results of the three batches of samples,the limitations of total content of echinacoside and acteoside,calycosin-7-glucoside were made.It was determined for the moment that each bag should contain no less than 2.82 mg of total content of echinacoside and acteoside,and 0.25 mg of calycosin-7-glucoside(9/bag).The determination method of total content of echinacoside and acteoside,calycosin-7-glucoside was established and the quality standard of the end products was established.Study on stability:The long-term stability test of 3 months and the accelerated stability test of 3 months were carried out.The results showed that the stable quality of preparation.In order to determine its actual validity period,this job is going on.