Pharmaceutical Study Of Yiqigutuo Granules

Constipation mainly pathological feature is large intestine conduction function dereliction of duty.The Yiqigutuo granule originated from clinical effective prescription which is change from Buzhongyiqitang and Dabuyuanjian which is the Classic prescription for the Treatment of uterine prolapse.The Yiqigutuo granule is composed of Astragaloside,Angelica,Radix dipsaci,Fructus Corni,Cimicifuga,Fructus aurantii,Terminalia,Silkworm.It has been used in the treatment of uterine prolapse which is asthenia of both the spleen and kidney,which is invigorate qi and strengthen the spleen,tonify the kidney and prevent the loss.The uterine prolapse which is asthenia of both the spleen and kidney belong to the TCM of Yinting and Yintuo.In explaining its medicine pathological mechanisms,from the "spleen fall","kidney failure solid" start.Patients because of overstrain,prolific,damage the spleen and kidney and send this disease.We need to remove inactive ingredients and retain the active ingredients to the greatest extent,reflect the comprehensive efficacy of compound preparation,but also need to make the finished products safe,effective,stable and controllable,to meet the clinical requirements.So,according to the requirements of Drug Registration of SFDA,we studied its raw materials,preparation process,quality standard and stability.The study details are as the following:Study on material:According to the relevant provisions of the Chinese Pharmacopoeia(edition 2010,part I),the raw materials of preparation were identified.The results are in line with the requirements and can be used in pharmaceutical research of Yiqigutuo granules.Study on preparation process:Analysis Prescription to determine its active ingredients,according to the physicochemical property of the active ingredients,the orthogonal experimental method was used for alcohol-soluble ingredients,water-soluble constituents of the preferred process to determine the best extraction process.1.The contents of Astragaloside and Ferulic acid and the yield of alcohol extract were used as indexes to optimize the alcohol extraction process of Astragaloside and Angelica by L9(34)orthogonal experiment.The optimized conditions are extracting 3 times with 10-fold total volume of 70%ethanol for 1.5 hours each time.And the optimum alcohol extraction process was verified.2.The content of polysaccharide,loganin and the yield of water extract were used as indexes to optimize the water extraction process ofFructus Corni and Silkworm by L9(34)orthogonal experiment.The optimized conditions are immersing 0.5 hour and extracting 2 times with 15-fold total volume of water for 2 hours each time.And the optimum water extraction process was verified.3.The alcohol precipitation of the water extract has been studied.The result is:the relative density of the water extract is 1.08?1.11(determined under 60 ?),adding ethanol to the extraction and making it a 50%alcohol solution,then letting it stand for 48 hours.4.Using the contents of loganin,Astragaloside and polysaccharide as indexes to optimize the enrichment and drying process.The optimized enrichment conditions are:the water-alcohol liquid was recycled ethanol and merged with the concentrated liquid of alcohol extract,then decompressive concentrated to the relative density for 1.05?1.08(60?)under 0.08 Mpa and 60?.Dry under reduced pressure with 70? and shatter extract powder.5.Preparation proeess for the granule has been optimized.The molding process conditions are:extract powder:dextrin:powdered sugar = 10:0.8:0.2.The method of wet particles is adopted with 80%ethanol.the particles obtained at 50 ? after pelletized.Study on quality standard:The study of quality standard with pilot sample.The characteristic compositions,standard crude drug and negative sample are taken as indexes with TLC to identify the quality of Astragaloside,Angelica,Radix dipsaci,Fructus Corni,Cimicifuga,Fructus aurantii,Terminalia,semi-works production's grade size,moisture,colliquation-character and so on,based on volume I C of pharmacopoeia of people's republic of china(edition 2010).The HPLC mensuration method for Astragaloside and Ferulic acid has been established for the quality standard of the Yiqigutuo Granule.The study of mensuration method is assessed,the result showed:The identified method of TLC of Astragaloside,Angelica et,spots is clear and well-separated without negative interference.The test of granule accord with the demand of Astragaloside and Ferulic acid show a good linear relationship during the linear ranges,respectively.The average recovery and RSD are all consistent with regulations.Meanwhile,the quality standard draft of Yiqigutuo granule in terms of Pharmacopoeia was drafted out.Study on stability:According to the demands of new drug and granule,the three test samples were initially at room temperature and acceleration(6 months)on the stability studies,and the result of the preparation quality is stable and controlled.In order to determine its actual validity period,this job is going on.The study results show that the preparation process is reasonable and practicable,the quality standard is controllable,and the quality of products is stable.