Study On The Manufacturing Process And Quality Specification Of Lead-Excretion Haiqi Tablet

Lead-Excretion Haiqi Tablet is a compound preparation that are made up of Lyciumbarbarum L.,Chrysanthemum morifolium (Ramat.) Tzvel., Lygodium japonicum (Thunb) Sw.and Fructus Mori. Chlorogenic acid and Polysaccharide are the effective constituent of it.Lead-Excretion Haiqi Tablethave many functions, such as to promote lead excretion, to relieveor prevent damaging on human body and to improve immunity. In order to make the compoundpreparation match with the lifestyle of modernist, we are devoting to study on ManufacturingProcess and Quality Specification ofLead-Excretion Haiqi Tablet.Using the content of chlorogenic acid and polysaccharide as indicator respectively, theoptimum extraction processes were investigated by single-factor analysis and orthogonal designtest. The optimum extraction process of chlorogenic acid was that Chrysanthemum morifoliumwas extracted with20folds of the amount of materials of75%alcohol for20minutes for onetime by ultrasonic method; the optimum extraction process of polysaccharide was as follows:extracting with15folds of the amount of materials of water for2times at90℃by refluxingmethod,1.5hours each time.Based on the results of investigation on the granulation of starch, microcrystalline cellulose,and mannitol with lower UV absorption, we found that microcrystalline were the best filler. Theoptimum technological factors, such as the dosage of excipient and the concentration ofmoistening agent, weredetermined by single-factor analysis. The result is as fellow: mixtures ofpolysaccharide and microcrystalline at a4:1ratio, mixtures of chlorogenic acid andmicrocrystalline at a3:2ratio,80%alcohol asmoistening agent,0.3%magnesium stearate aslubricating agent, wet granulation, drying step, granulating, and tablet compression.The quality of Haiqi tablet is consistent with the request of appendix ID about tablets ofChinese Pharmacopoeia2010edition. Chlorogenic acid is identified by TLC and HPLC. Thecontent of chlorogenic acid is determined by HPLC, and the content of polysaccharide isdetermined by UV. Three batches of product have passed quality inspections according toquality specification.