The Preparation And Quality Assessment Of Oleanolic Acid Dropping Pills

This paper study superfine crushing and dripping pill preparation technology,which is used PEG4000 as matrix material, by melting method to prepare oleanolicacid dropping pills. At the same time, the prescription, preparation process, qualitystandard and stability were studied. To solve the oleanolic acid pharmaceutical dosageforms a single, clinical application, further improvement of oleanolic acid droppingpill preparation delivery systems research and development platform for thedevelopment of Chinese medicine pill preparation.In the paper, the main work and conclusions are as follows:The best prescription of oleanolic acid dropping pills is optimized anddetermined through using the technology of superfine grinding process of oleanolicacid medicine, with the dissolving time and roundness as the main evaluation index.With the main drug proportion, temperature of condensate, dropping distance for theinvestigation of factors, the orthogonal experiment L₉(3)⁴ and variance analysis pillmolding process optimization. HPLC method measures the content of oleanolic aciddropping pills drug, tests dropping pills dissolution of oleanolic acid, and develop theproduct quality control protocol, preliminarily inspected pills stability.Results: The indicators of oleanolic acid dropping pills using superfine powderprocessing are better than the untreated. Oleanolic acid dropping pills prescriptionconditions: the oleanolic acid is joined in PEG4000 molten state and mixing together(the ratio of the oleanolic acid and PEG4000 is 1: 5). Then it is drop into thecondenser pipe filled dimethyl silicone with dripping of diameter 3mm, diameter4mm, dripping distance 7cm (Condensation temperature: 15±5℃). Finallypreparation pills by cleaning to remove surface condensing agent can be packaged andmeets quality requirements. The good linear relationship (r=0.9997, n = 6 ), samplerecovery rate was 98.58%103.03% (n = 6) and RSD=0.06% shows with the oleanolicacid concentration 0.020740.07259mg/mL. Dissolution rate of oleanonlic acidreached 95.33% at 45min, which is much higher than ordinary tablet (5.2%) anddispersible tablet (52.17%). The factors greatly affect the stability of test with hightemperature (60±2)℃, high humidity (25℃, RH92.5%±5%). However, thestability are good at high temperature (40±2)℃, light(4500lx±500lx). Thehygroscopic behavior of oleanolic acid dropping pills has a presence at high humidity(25℃,R H75％±5ï¼…). At the same time the pills weight increase. With the packagingcondition, the stability index did not change significantly by accelerated test and roomtemperature test.Conclusion: the process of prescription and preparing method can meet qualityrequirements. On the basis of quality standards of oleanolic acid existing, the qualitystandards for oleanolic acid dropping pills is forwarded at the first. Pills should besealed, moistureproof,cooled and dry stored.