Study on the Preparation Technology of Fanhuncao Sustained-release Dropping Pills / 中国药房

ABSTRACT

OBJECTIVE:To study the preparation technology of Fanhuncao sustained-release dropping pills. METHODS:The preparation technology of Fanhuncao sustained-release dropping pills was optimized by orthogonal design and single factor test with PEG4000,PEG6000 and glycerol monostearate(GM)as carrier materials,using sphericity,pill weight difference and appearance quality as index,GM-PEG weight ratio,liquid temperature,nozzle temperature,dipping speed,dropping distance,diameter of emitter as factors and the verification test was conducted. RESULTS:The optimal technology was that the ratio of GM-PEG was 3∶7;the temperature of drug mixture was 85 ℃;the dropping speed was 40 drop/min;dropping distance was 4 cm;and the conden-sate temperature was 15 ℃;diameter of emitter was 4 mm. RSD of each index of 3 batches of dripping pills were all ≤0.58%(n=3)in verification test;the average content of chlorogenic acid was 0.14 mg/g;the average pill weight difference was 3.21%;the average sphericity was 9.43;and the average appearance quality was 4.33. Q1 h were 23.4%,24.4% and 23.3% in average(n=6),and Q12 h were 89.6%,91.2% and 91.5%(n=6). CONCLUSIONS:The optimal preparation technology is stable and simple, and can be used for industrial production of Fanhuncao sustained-release dropping pills.