Studies On The Pharmaceutial Of Xianggezhengqi Capsule

Xianggezhengqi capsule is a compound preparation.It composed of Herba Pogostemonis,Cortex Magnoliae officinalis,Flos Caryophylli,Rhizoma Atractylodis macrocephalae,Pericarpium Citri reticulatae,Folium Perillae, Radix Puerariae lobatae,Radix Platycodonis,Poria,Pericarpium Arecae, Rhizoma Zingiberis recens,Radix et Rhizoma Glycyrrhizae and Fructus Jujubae. The efficacy of Xianggezhengqi capsule is invigorating spleen to resolve the dampness and eliminating the fullness in the chest,which can be used to treat the symptoms caused by the disease pattern of dampness obstructing the spleen-stomach as follows syndrome:anorexia,stomach cold,abdominal pain, fullness in the abdominal,nausea,vomit,acid regurgitation,and belching. We have summaried the literature about the chemical composition and assaying and pharmacology of each herb of Xianggezhengqi prescription,we have done the experiment study on preparation process,the quality standard and the stability of the capsule.1.To establish the preparation process of Xianggezhengqi capsule. According to clinical drug characteristics and the nature of drugs,we determined dosage form of capsule.Use orthogonal experiment to optimize the extraction process.The supercritical fluid extraction process of Herba Pogostemonis,Cortex Magnoliae officinalis,Flos Caryophylli,Rhizoma Atractylodis macrocephalae,Rhizoma Zingiberis recens,Folium Perillae and Pericarpium Citri reticulatae:With the rate of supercritical extractive as the index,optimization of supercritical extraction process for the extraction temperature of 45℃,extraction pressure on the 26MPa,extraction time 3h. The alcohol extraction process of Radix Puerariae lobatae,Radix Platycodonis, Radix et Rhizoma Glycyrrhizae,Pericarpium Arecae,Fructus Jujubae and the dregs of SFE-CO₂:With the total amount of the solid alcohol extractive as the index,optimization of alcohol extraction process for:six times in 60% alcohol,three times,each time for one hour.The results showed that drying process,by adding 10 percent of the total solids ofβ-CD,spray drying can proceed smoothly.The results of shaping process show that the optimal parameters for the dry-pressed particle are:the feed rate of 48 rpm,pressure roller speed 30 rpm,granulation speed 30 rpm;critical relative humidity of about 71.8%;powder made of particles,its hygroscopicity and mobility Have greatly improved,the choice will be installed after the powder particles system capsule;capsule from the 1st packaging,with an average of about 0.37 g.2.To establish the quality standard and the method for quality control of the capsule.For control the quality of Xianggezhengqi capsule,we studied the quality standard of it.Determined the contents of eugenol,magnolol,and honokiol by gas chromatography(GC);identified the patchouli alcohol of Herba Pogostemonis,puerarin of Radix Puerariae lobatae,hesperidin of Pericarpium Citri reticulatae and Rhizoma Atractylodis macrocephalae by thin layer chromatography(TLC);Studies on the identification of the relevant chromatographic peak in Herba Pogostemonis,Rhizoma Atractylodis macrocephalae and Folium Perillae by GC.The experiment indicated that the established TLC identification method has a good reproducibility,and the TCL stain is distinctly,with a non-interferential control stain.At the same time,we did a systemic methodology research on the assaying method,and the blank is no interferential too;it indicated that eugenol has a good linear relationship at a range of 62.5～500μg·ml^-1,the regression equation is Y= 13346X+274.29,the coefficient correlation(r)is 0.9995;magnolol has a good linear relationship at a range of 15.75～150μg·ml^-1,the regression equation is Y=3106.4X-232.75,the coefficient correlation(r)is 0.9991;honokiol has a good linear relationship at a range of 20～160μg·ml^-1,the regression equation is Y=3288.7X-6.0714,the coefficient correlation(r)is0.9994.The RSD of repetitiveness test results of eugenol,magnolol,and honokiol are 2.04 %,1.63%,1.87%respectively,and the average recovery are 100.72%,100.05 %99.94%,and RSD are 1.03%,1.06%,1.06%respectively. 3.To investigate the stability of the capsule.According to technical requ-irements for registration of pharmaceuticals,we investigated the stability of 3 lots of capsule that packaged as market by sample-keeping observation method for 3 months.The experiment indicated that this capsule could maintain stable in room temperature for 3 months.The established preparation process of Xiangge zhengqi capsule is reasonable and feasible,and the established quality standard of it can control the quality of it in many sides.